FDA 510(k) Application Details - K234125

Device Classification Name	More FDA Info for this Device
510(K) Number	K234125
Device Name	AtriClip FLEX-Mini LAA Exclusion System (ACHM)
Applicant	AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Stephanie Hadnot 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	12/28/2023
Decision Date	07/29/2024
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