510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991683Substantially Equivalent

PTFE Ringed Gore-Tex Vascular Graft

W. L. Gore & Associates, Inc., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991683 is the FDA 510(k) clearance record for PTFE RINGED GORE-TEX VASCULAR GRAFT, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K991683.

Clearance record

Decision date
Received
(114 days to decision)
Product code
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 3250 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary
Third party review
No

Clearances, product code DYF

Trailing 12 months

FDA records hold no clearances under product code DYF in the trailing twelve months.

FDA records show no clearances under product code DYF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260