510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821826Substantially Equivalent

Fep-Ringed Gore-Tex@ Vascular Graft

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

K821826 is the FDA 510(k) clearance record for FEP-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 K821826.

Clearance record

Decision date
Received
(190 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. 4221 Richmond Rd., NW, Walker MI
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