FDA 510(k) Application Details - K050684

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K050684
Device Name	Catheter, Intravascular, Diagnostic
Applicant	BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY FREMONT, CA 94538-6515 US Other 510(k) Applications for this Company
Contact	ROBERT Z PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2005
Decision Date	05/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review