510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033670Substantially Equivalent

Gore Tri-Lobe Balloon Catheter

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

K033670 is the FDA 510(k) clearance record for GORE TRI-LOBE BALLOON CATHETER, a class II device, cleared for W. L. Gore & Associates, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K033670.

Clearance record

Decision date
Received
(163 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
W. L. Gore & Associates, Inc. 3450 W. Kiltie Ln., Flagstaff AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260