What are the regulatory approvals for the GORE VIABAHN Endoprosthesis?

The GORE VIABAHN Endoprosthesis has received FDA 510K clearance, FDA PMA approval, and MDD authorization. These regulatory approvals indicate that the device has been evaluated and deemed safe and effective for its intended use in treating superficial femoral artery lesions.

What sizes are available for the GORE VIABAHN Endoprosthesis?

The GORE VIABAHN Endoprosthesis is available in various sizes to accommodate reference vessel diameters ranging from 4.8 to 7.5 mm. The specific sizes and models should be selected based on the patient's anatomy and the specific requirements of the procedure.

GORE VIABAHN Endoprosthesis

by W. L. Gore & Associates, Inc.

PMA P040037510(k) K013648Ref PACR070202E, PACR060501E, PAC091002E, PACR060502E, PACR050202E, PACR061501E, PAC050202, PAC071501, PACR081001E, PAC101502, PAC060502, PAC071001, PACR051502E, PAC080202, PAC051502, PAC081001, PAC071502, PAC081002, PAC091502E, PAC100502, PAC090502E, PAC070202, PACR080502E, PAC100502E, PACR071002E, PAC070502, PAC101002, PACR060202E, PAC111002E, PAC051002, PACR080501E, PAC061002, PACR081501E, PAC101502E, PAC080501, PAC111002, PACR071001E

Active Active in United States. Withdrawn in European Union.

CE MDD PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P040037↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00733132627318 Basic UDI-DI	Date8 May 2026Registered	StatusWithdrawn
United States	FDA PMA PMA	NumberP040037	Date14 Jun 2005Approved	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK013648	Date8 Jan 2002Cleared	StatusActive

Certificates

0 certificates · EUDAMED

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

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

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Withdrawn
United States FDA 510(k), FDA PMA Active

Specification

EUDAMED · 510(k) · PMA

Trade Name: GORE® VIABAHN® Endoprosthesis EUDAMED
Viabahn Endoprosthesis PMA
Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
Model / Reference: PACR070202E, PACR060501E, PAC091002E, PACR060502E, PACR050202E, PACR061501E, PAC050202, PAC071501, PACR081001E, PAC101502, PAC060502, PAC071001, PACR051502E, PAC080202, PAC051502, PAC081001, PAC071502, PAC081002, PAC091502E, PAC100502, PAC090502E, PAC070202, PACR080502E, PAC100502E, PACR071002E, PAC070502, PAC101002, PACR060202E, PAC111002E, PAC051002, PACR080501E, PAC061002, PACR081501E, PAC101502E, PAC080501, PAC111002, PACR071001E

Primary DI / UDI-DI: 00733132627318, 00733132627257, 00733132627592, 00733132627264, 00733132623327, 00733132627295, 00733132607785, 00733132607945, 00733132627400, 00733132608089, 00733132607846, 00733132607921, 00733132627523, 00733132607969, 00733132607815, 00733132607990, 00733132607952, 00733132608003, 00733132627608, 00733132608065, 00733132627585, 00733132607891, 00733132627394, 00733132627615, 00733132627554, 00733132607914, 00733132608072, 00733132627530, 00733132627653, 00733132607808, 00733132627387, 00733132607860, 00733132627578, 00733132627639, 00733132607976, 00733132608102, 00733132627349
Basic UDI-DI: B-00733132627318, B-00733132627257, B-00733132627592, B-00733132627264, B-00733132623327, B-00733132627295, B-00733132607785, B-00733132607945, B-00733132627400, B-00733132608089, B-00733132607846, B-00733132607921, B-00733132627523, B-00733132607969, B-00733132607815, B-00733132607990, B-00733132607952, B-00733132608003, B-00733132627608, B-00733132608065, B-00733132627585, B-00733132607891, B-00733132627394, B-00733132627615, B-00733132627554, B-00733132607914, B-00733132608072, B-00733132627530, B-00733132627653, B-00733132607808, B-00733132627387, B-00733132607860, B-00733132627578, B-00733132627639, B-00733132607976, B-00733132608102, B-00733132627349
PMA Number: P040037
510(k) Number: K013648
FDA Product Code: JCT
EMDN Code: P0704020203 Peripheral vascular drug eluting stents (des)

Device Class: Class IIb EUDAMED
Class II PMA
Regulation: 21 CFR Part 878.3720
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	PMA
Device Class	EUDAMED Class IIb	PMA Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The GORE VIABAHN Endoprosthesis is a stent designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. It is manufactured by W. L. Gore & Associates, Inc.

The device is indicated for use in superficial femoral artery lesions and is available in various sizes. It has received FDA 510K clearance, FDA PMA approval, and MDD authorization. The device is supplied as a single-use implant and should be stored according to the manufacturer's instructions.

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Questions

AI-generated answers, 18 Sep 2026