FDA 510(k) Application Details - K181474

Device Classification Name	More FDA Info for this Device
510(K) Number	K181474
Device Name	ArtiClip LAA Exclusion System
Applicant	AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Jonathan McElwee 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	06/04/2018
Decision Date	06/28/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review