FDA 510(k) Application Details - K130827

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K130827
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	TOPERA, INC. 3668 S. GEYER ROAD SUITE 365 ST. LOUIS, MO 63127 US Other 510(k) Applications for this Company
Contact	MELISSA WALKER 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	03/26/2013
Decision Date	10/31/2013
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