Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Gore Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface

Generic Name

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

PMA Number

P130006 ↗

FDA Product Code

PFV

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

  Class III

  CE/MDR MDR 732278 Expiring Valid to Feb 2027

• GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

  Class III

  CE/MDR MDR 731181 Active Valid to Jul 2031

• GORE-TEX® Stretch Vascular Graft

  Class III

  CE/MDR MDR 732281 Active Valid to Jul 2031

• GORE® EXCLUDER® Iliac Branch Endoprosthesis

  Class III

  CE/MDR MDR 731176 Active Valid to Jul 2031

• GORE® DrySeal Flex Introducer Sheath

  Class III

  CE/MDR MDR 764343 Active Valid to Apr 2028

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

  Class III

  CE/MDR MDR 731175 Active Valid to Jul 2031

See all devices from W. L. Gore & Associates, Inc. →

• What specific vascular conditions is the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface designed to treat?

  This device is specifically designed to treat stenosis (narrowing) or thrombotic occlusion (blockage due to clot) at the venous anastomosis—where an artificial graft connects to a vein—in synthetic arteriovenous (AV) dialysis access circuits. It is not intended for general vascular stenosis or other types of vascular interventions.

• How is the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface supplied, and is it reusable?

  The device is supplied sterile and intended for **single-use only** in interventional radiology or vascular surgery settings. It must be handled under sterile conditions as per regulatory guidelines, and reuse is not recommended or approved.

• What sizes or models are available for the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface?

  The device comes in multiple sizes, each identified by unique registration numbers (e.g., 1721676, 3015225571, etc.). These numbers correspond to specific diameters and lengths tailored for different patient anatomies and procedural needs. Contact the manufacturer for detailed sizing charts or to confirm availability of a particular size.

• Does the heparin bioactive surface require any special handling or storage instructions?

  While the heparin bioactive surface is designed to reduce thrombogenicity, the device itself remains sterile upon packaging and must be stored according to manufacturer instructions (typically refrigerated or at room temperature, as specified). It should only be used once and handled with sterile techniques to maintain its integrity and efficacy.

• What regulatory pathway was followed for approval of this device, and how does that affect its use?

  The Gore Viabahn Endoprosthesis with Heparin Bioactive Surface was approved via the FDA’s **Premarket Approval (PMA) pathway (P130006)**, which requires rigorous clinical evidence demonstrating safety and effectiveness. This approval is specific to treating stenosis or occlusion at the venous anastomosis of synthetic AV dialysis grafts, and its use must adhere to the approved indications and labeling.