FDA 510(k), K233407, AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

Device Classification Name: Left Atrial Appendage Clip, Implantable
510(k) Number: 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.
Regulation Number: 878.4300
Classification Product Code: PZX
Subsequent Product Code: FZX
Date Received: 10/05/2023
Decision Date: 11/02/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: Cardiovascular