FDA 510(k) Application Details - K243860

Device Classification Name	More FDA Info for this Device
510(K) Number	K243860
Device Name	AtriClip PRO-Mini LAA Exclusion System (PROM)
Applicant	AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Diane Sung 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	12/16/2024
Decision Date	01/15/2025
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