Skip to content

Fed Ringed-Tex Vascular Graft

by W. L. Gore & Associates, Inc.

510(k) K821158

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821158 Date18 May 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Fed Ringed-Tex Vascular Graft is a prosthetic vascular graft designed for use in cardiovascular procedures. It is classified as a vascular graft with a diameter of 6 mm or greater, intended to replace or bypass damaged blood vessels in the body. Constructed with ringed reinforcement, this graft provides structural support to maintain patency and reduce the risk of aneurysm formation or dilation over time.

This device is supplied sterile and intended for single-use in surgical settings. It is manufactured from expanded polytetrafluoroethylene (ePTFE) with external ring reinforcement to enhance durability and reduce trauma during implantation. The Fed Ringed-Tex Vascular Graft has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent, Same Essential Features). It is regulated under the classification of Class II, Prosthesis, Vascular Graft, and falls under the product code DSY.

Other devices from W. L. Gore & Associates, Inc.

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