FDA 510(k) Application Details - K163709

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K163709
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	ABBOTT ELECTROPHYSIOLOGY 1530 OBRIEN DRIVE SUITE B MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	DENNIS POZZO 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	12/30/2016
Decision Date	02/28/2017
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