510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062161Substantially Equivalent

Gore Propaten Vascular Graft

W. L. Gore & Associates, Inc., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062161 is the FDA 510(k) clearance record for GORE PROPATEN VASCULAR GRAFT, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show 2 recalls naming K062161.

Clearance record

Decision date
Received
(104 days to decision)
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 1505 N. Fourth St., Flagstaff AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSY

Trailing 12 months
1 clearance under product code DSY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260