FDA 510(k) Application Details - K120425

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K120425
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. DIAMOND BAR, CA 91765 US Other 510(k) Applications for this Company
Contact	WAYNE R HOHMAN 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	02/13/2012
Decision Date	05/24/2012
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