510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153500Substantially Equivalent

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip

AtriCure, Inc., West Chester OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153500 is the FDA 510(k) clearance record for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip, a class II device, cleared for AtriCure, Inc. on under FDA product code FZP (Clip, Implantable). FDA records list 59 510(k) clearances for AtriCure, Inc., from to . As of , FDA records show no recalls naming K153500.

Clearance record

Decision date
Received
(51 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
AtriCure, Inc. 6217 Centre Park Dr., West Chester OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260