FDA 510(k) Application Details - K050577

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K050577
Device Name	Catheter, Intravascular, Diagnostic
Applicant	BOSTON SCIENTIFIC CORP. 47201 LAKEVIEW BLVD. FREMONT, CA 94537 US Other 510(k) Applications for this Company
Contact	VERONICA M KOCKEN 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	03/07/2005
Decision Date	03/30/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review