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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K233407
FOIA Releasable 510(k) K233407
Device Name AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Stephanie Hadnot
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Stephanie Hadnot
Regulation Number878.4300
Classification Product Code
PZX  
Subsequent Product Code
FZX  
Date Received10/05/2023
Decision Date 11/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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