Modification to Viabahn Endoprosthesis

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

GORE® VIABAHN® Endoprosthesis

Model / Reference

PACR061002E

Primary DI / UDI-DI

00733132627288

Basic UDI-DI

B-00733132627288

510(k) Number

K023811 ↗

FDA Product Code

JCT

EMDN Code

P0704020203 Peripheral vascular drug eluting stents (des)

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 878.3720

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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 is the Viabahn Endoprosthesis used for?

  The Viabahn Endoprosthesis is a stent graft used in endovascular procedures to treat peripheral vascular diseases, particularly to provide patency in complex cases such as superficial femoral artery chronic total occlusion.

• Is the Viabahn Endoprosthesis single-use or reusable?

  The Viabahn Endoprosthesis is supplied as a single-use implant, meaning it should be used only once for each patient and then discarded.

• What regulatory approvals does the Viabahn Endoprosthesis have?

  The Viabahn Endoprosthesis has received FDA 510(k) clearance and is classified under the Medical Device Directive (MDD), indicating it meets regulatory requirements for safety and performance.

• How is the Viabahn Endoprosthesis supplied?

  The device is supplied as a single-use implant manufactured by W. L. Gore & Associates, Inc., though specific details about packaging or sizes are not provided in the available information.