FDA 510(k) Application Details - K983171

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K983171
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	STEVE JWANOUSKOS 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	09/10/1998
Decision Date	03/11/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review