FDA 510(k) Application Details - K111043

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K111043
Device Name	Catheter, Ultrasound, Intravascular
Applicant	BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY FREMONT, CA 94538-6515 US Other 510(k) Applications for this Company
Contact	JANICE E BROWN, RAC Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2011
Decision Date	08/04/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review