FDA 510(k) Application Details - K012926

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K012926
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	ENDOCARDIAL SOLUTIONS, INC. 1350 ENERGY LN., SUITE 110 ST. PAUL, MN 55108 US Other 510(k) Applications for this Company
Contact	ERIC W KOEHLER 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	08/31/2001
Decision Date	09/28/2001
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review