FDA 510(k) Application Details - K191413

Device Classification Name	More FDA Info for this Device
510(K) Number	K191413
Device Name	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
Applicant	AtriCure, Inc 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Jim Taufen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2019
Decision Date	08/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review