FDA 510(k) Application Details - K172393

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K172393
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	St. Jude Medical, Inc. 5050 Nathan Lane N Plymouth, MN 55442 US Other 510(k) Applications for this Company
Contact	Jennifer Ruether 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	08/08/2017
Decision Date	04/23/2018
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