{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Venclose Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/venclose-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/venclose-inc",
    "json_url": "https://devicerts.com/manufacturers/venclose-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/venclose-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/manufacturers/venclose-inc",
    "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."
  },
  "manufacturer": {
    "name": "Venclose Inc",
    "url": "https://devicerts.com/manufacturers/venclose-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000001372"
      },
      {
        "label": "DUNS",
        "value": "085838983"
      }
    ],
    "summary": "Venclose Inc is a medical device manufacturer based in the United States, with 26 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIb) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 26,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 22
      },
      {
        "registry": "EUDAMED",
        "devices": 9
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 17
      },
      {
        "class": "EU Class I",
        "devices": 6
      },
      {
        "class": "EU Class IIb",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 7
      },
      {
        "code": "C01",
        "name": "Arterio-venous system devices",
        "url": "https://devicerts.com/categories/emdn/C01",
        "devices": 2
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "ICON (LR) Limited",
        "url": "https://devicerts.com/representatives/icon-lr-limited-ie-ar-000006507",
        "country": "Ireland"
      }
    ]
  },
  "devices": {
    "shown": 26,
    "total": 26,
    "all_devices_url": "https://devicerts.com/manufacturers/venclose-inc",
    "items": [
      {
        "name": "Venclose System Power Cord VCPCN",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpcn",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose™ EVSRF™ Catheter VC-10A2.5-6F-60 [10X]",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60-10x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose System Power Cord VCPCC",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpcc",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose System Power Cord VCPCH",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpch",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose Maven Catheter VC056F",
        "url": "https://devicerts.com/devices/venclose-maven-catheter-vc056f",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose™ EVSRF™ Catheter VC-10A2.5-6F-100 [10X]",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100-10x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose™ EVSRF™ Catheter VC-10A2.5-6F-60 [5X]",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60-5x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose System Power Cord VCPCB",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpcb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose™ EVSRF™ Catheter VC-10A2.5-6F-100 [5X]",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100-5x",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "EVSRF Procedure Pack VC-PP-EVSRF",
        "url": "https://devicerts.com/devices/evsrf-procedure-pack-vc-pp-evsrf",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose System Power Cord VCPCA",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpca",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose System Foot Pedal VCFP1",
        "url": "https://devicerts.com/devices/venclose-system-foot-pedal-vcfp1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose System Power Cord VCPCM",
        "url": "https://devicerts.com/devices/venclose-system-power-cord-vcpcm",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-i",
        "model_reference": "VC-PC-I",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose digiRF Generator (VCRFG1)",
        "url": "https://devicerts.com/devices/venclose-digirf-generator-vcrfg1-gei",
        "model_reference": "K250068",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-02-04",
        "open_recall": true
      },
      {
        "name": "Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter",
        "url": "https://devicerts.com/devices/venclose-digirf-generator-with-maven-catheter-venclose-maven-gei",
        "model_reference": "K211806",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2021-08-03",
        "open_recall": true
      },
      {
        "name": "Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)",
        "url": "https://devicerts.com/devices/venclose-radiofrequency-system-digirf-generator-evsrf-cathet-gei",
        "model_reference": "K160754",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2016-09-09",
        "open_recall": true
      },
      {
        "name": "Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)",
        "url": "https://devicerts.com/devices/venclose-digirf-generator-vcrfg1-venclose-evsrf-catheter-vc1-gei",
        "model_reference": "K252316",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-08-19",
        "open_recall": false
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-l",
        "model_reference": "VC-PC-L",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose EVSRF Catheter",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60",
        "model_reference": "VC-10A2.5-6F-60",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-k",
        "model_reference": "VC-PC-K",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-j",
        "model_reference": "VC-PC-J",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose EVSRF Catheter",
        "url": "https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100",
        "model_reference": "VC-10A2.5-6F-100",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-g",
        "model_reference": "VC-PC-G",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose Power Cord",
        "url": "https://devicerts.com/devices/venclose-power-cord-vc-pc-e",
        "model_reference": "VC-PC-E",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Venclose digiRF Generator",
        "url": "https://devicerts.com/devices/venclose-digirf-generator-vc-rfg-1",
        "model_reference": "VC-RFG-1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "10000475258-PA-NoMA-USA",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "DNV Product Assurance AS",
      "issued": "2023-08-29",
      "expires": "2028-08-29",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}