{
  "format": "devicerts.device.v1",
  "cite_as": "Temporary Pacemaker Ground Wire, Scholten Surgical Instruments, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb (data as of 2026-11-15).",
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    "markdown_url": "https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
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    "registry_records_last_synced": "2026-10-22",
    "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/temporary-pacemaker-ground-wire-dtb",
    "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": "Temporary Pacemaker Ground Wire",
    "registry_name": "TEMPORARY PACEMAKER GROUND WIRE",
    "url": "https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb",
    "manufacturer": {
      "name": "Scholten Surgical Instruments, Inc.",
      "url": "https://devicerts.com/manufacturers/scholten-surgical-instruments-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
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    "identifiers": [
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        "values": [
          {
            "value": "K852119",
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "DTB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Temporary Pacemaker Ground Wire is a flexible insulated electrical conductor designed to connect an external temporary pacemaker pulse generator to the patient’s heart. It facilitates temporary cardiac pacing to manage bradycardia during surgical or diagnostic procedures, ensuring stable heart rhythm when endogenous conduction is compromised.\n\nThis device is intended for single-use in hospital operating rooms, electrophysiology labs, or cardiac catheterization suites. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance (K852119) under the classification of Class III (DTB). No MRI safety or reusable specifications are noted in the regulatory data.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K852119",
      "number_label": null,
      "device_udi_di": null,
      "date": "1985-09-15",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
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          "label": "510(k) Number",
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            {
              "value": "K852119",
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        {
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}