FDA 510(k) Application Details - K211438

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K211438
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	John Jimenez 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	05/10/2021
Decision Date	03/18/2022
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