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Gore-Tes Expanded PTFE Patch

by W. L. Gore & Associates, Inc.

510(k) K821717

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 NumberK821717 Date12 Jan 1983ClearedStatusActive

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  • Withdrawn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
DXZ
Device class
Class II
Regulation
21 CFR Part 870.3470
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 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-Tes Expanded PTFE Patch is a cardiovascular device classified as a patch, pledget, and intracardiac material. It is designed for use in cardiovascular surgical procedures.

This device is authorized under FDA 510(k) clearance K821717. It is manufactured by W. L. Gore & Associates, Inc.

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