FDA 510(k) Application Details - K223666

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K223666
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	Ablacon, Inc. 4800 Wadsworth Blvd Suite 310 Wheat Ridge, CO 80033 US Other 510(k) Applications for this Company
Contact	Frank Rodriguez Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	MTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2022
Decision Date	03/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review