FDA Device Intelligence
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System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA product code PFV · Class 3 · Unknown

478
Registered devices
2,787
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.WRAPSODY® — Merit Medical Systems, Inc.Flair® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.Fluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.COVERA — Angiomed GmbH & Co. Medizintechnik KGFlair® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.COVERA — Angiomed GmbH & Co. Medizintechnik KGGORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.Fluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.Fluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.Fluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.Flair® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.COVERA — Angiomed GmbH & Co. Medizintechnik KGFluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis with Heparin — W. L. Gore & Associates, Inc.Fluency® Endovascular Stent Graft — Bard Peripheral Vascular, Inc.GORE VIABAHN Endoprosthesis — W. L. Gore & Associates, Inc.

Recent recalls

DateFirmReason
2022-12-22Bard Peripheral Vascular IncAn increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.