FDA 510(k) Application Details - K003782

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K003782
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	ANDREA BOUMIS 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	12/07/2000
Decision Date	02/14/2001
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