{ "format": "devicerts.device.v1", "cite_as": "Arrow IPN000257, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-iab-06830-u (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/arrow-iab-06830-u", "json_url": "https://devicerts.com/devices/arrow-iab-06830-u.json", "markdown_url": "https://devicerts.com/devices/arrow-iab-06830-u.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-24", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/arrow-iab-06830-u", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "Arrow IPN000257", "registry_name": "ARROW IPN000257", "url": "https://devicerts.com/devices/arrow-iab-06830-u", "manufacturer": { "name": "Teleflex Incorporated", "url": "https://devicerts.com/manufacturers/teleflex-incorporated", "country": null, "country_basis": null, "fda_registration_country": "United States" }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class III", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "IAB-06830-U", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00801902003751", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00801902003751", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K000729", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "DSP" ], "emdn": [ { "code": "C019001", "term": "AORTIC COUNTERPULSATION CATHETERS" } ], "gmdn": [ { "code": "34919", "term": "Intra-aortic balloon catheter" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-00801902003751", "number_label": "Basic UDI-DI", "device_udi_di": "00801902003751", "date": "2026-08-04", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00801902003751", "number_label": "UDI-DI", "device_udi_di": null, "date": "2015-10-16", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K000729", "number_label": null, "device_udi_di": null, "date": "2000-05-19", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1879-2024", "classification": "Class I", "status": "ongoing", "initiated": "2024-04-29", "reason": "Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: \n-failure of the intra-aortic balloon to completely inflate over its full length\n-damaged or broken central lumen in the segment contained within the balloon\n-helium loss or blood in the helium pathway.", "applies": "this device", "via": "K000729" }, { "number": "Z-1880-2024", "classification": "Class I", "status": "ongoing", "initiated": "2024-04-29", "reason": "Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: \n-failure of the intra-aortic balloon to completely inflate over its full length\n-damaged or broken central lumen in the segment contained within the balloon\n-helium loss or blood in the helium pathway.", "applies": "this device", "via": "K000729" }, { "number": "Z-1059-2016", "classification": "Class I", "status": "terminated", "initiated": "2016-02-10", "reason": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.", "applies": "this device", "via": "K000729" }, { "number": "Z-1062-2016", "classification": "Class I", "status": "terminated", "initiated": "2016-02-10", "reason": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.", "applies": "this device", "via": "K000729" }, { "number": "Z-1060-2016", "classification": "Class I", "status": "terminated", "initiated": "2016-02-10", "reason": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.", "applies": "this device", "via": "K000729" }, { "number": "Z-1058-2016", "classification": "Class I", "status": "terminated", "initiated": "2016-02-10", "reason": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.", "applies": "this device", "via": "K000729" }, { "number": "Z-1056-2016", "classification": "Class I", "status": "terminated", "initiated": "2016-02-10", "reason": "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.", "applies": "this device", "via": "K000729" }, { "number": "Z-1064-2013", "classification": "Class II", "status": "terminated", "initiated": "2012-11-27", "reason": "Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of\nthe catheter.", "applies": "this device", "via": "K000729" }, { "number": "Z-1065-2013", "classification": "Class II", "status": "terminated", "initiated": "2012-11-27", "reason": "Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of\nthe catheter.", "applies": "this device", "via": "K000729" }, { "number": "Z-0792-2011", "classification": "", "status": "terminated", "initiated": "2010-10-11", "reason": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "applies": "this device", "via": "K000729" }, { "number": "Z-0969-2011", "classification": "", "status": "terminated", "initiated": "2010-10-11", "reason": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "applies": "this device", "via": "K000729" }, { "number": "Z-0790-2011", "classification": "", "status": "terminated", "initiated": "2010-10-11", "reason": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "applies": "this device", "via": "K000729" }, { "number": "Z-0793-2011", "classification": "", "status": "terminated", "initiated": "2010-10-11", "reason": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "applies": "this device", "via": "K000729" }, { "number": "Z-0791-2011", "classification": "", "status": "terminated", "initiated": "2010-10-11", "reason": "SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.", "applies": "this device", "via": "K000729" }, { "number": "Z-1215-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1222-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1221-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1220-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1214-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1213-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1211-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1217-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1219-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1218-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1216-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1210-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" }, { "number": "Z-1212-2009", "classification": "", "status": "terminated", "initiated": "2009-02-02", "reason": "A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.", "applies": "this device", "via": "K000729" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "UltraFlex(TM) IAB", "registries": [ "EUDAMED" ] }, { "value": "ARROW", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Intra-aortic balloon catheter", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "UltraFlex IAB: 7.5Fr 30cc", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "IAB-06830-U", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "IPN000257", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00801902003751", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00801902003751", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K000729", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "DSP", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "C019001", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Intra-aortic balloon catheter", "code": "34919", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class III", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "870.3535", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Ireland", "registries": [ "EUDAMED" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Dimensions & Sizes", "fields": [ { "label": "Size", "values": [ { "value": "Total Volume — 30 Milliliter", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "Yes", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains endocrine-disrupting substances", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }