FDA 510(k) Application Details - K034061

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K034061
Device Name	Introducer, Catheter
Applicant	BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	CHRISTINA L ROWE Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2003
Decision Date	01/30/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review