510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K092563Substantially Equivalent

Gator Clipseal Plug

Vascular Solutions LLC, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092563 is the FDA 510(k) clearance record for GATOR CLIPSEAL PLUG, a class II device, cleared for Vascular Solutions, Inc. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 115 510(k) clearances for Vascular Solutions, Inc., from to . As of , FDA records show no recalls naming K092563.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation
21 CFR 870.4290
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascular Solutions, Inc. 6464 Sycamore Ct., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTL

Trailing 12 months

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

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