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Gore-Tex Vascular Graft

by W. L. Gore & Associates, Inc.

510(k) K880167

Active United States. Also listed in GUDID (US), not in commercial distribution.

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), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00733132611140 UDI-DI Date10 Jan 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK880167 Date18 May 1988ClearedStatusActive

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  • Withdrawn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) · GUDID

Generic Name
Synthetic vascular graft, non-medicated
Model / Ref / Catalog
RRT10030030L
Primary DI / UDI-DI
00733132611140
510(k) Number
FDA Product Code
DSY
GMDN Term
Synthetic vascular graft, non-medicated
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 10 Millimeter
Length — 30 Centimeter

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No