FDA 510(k) Application Details - K122405

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K122405
Device Name	Clamp, Vascular
Applicant	DATASCOPE CORP., CARDIAC ASSIST DIVISION 15 LAW DR. FAIRFIELD, NJ 07004-0011 US Other 510(k) Applications for this Company
Contact	CARLA S CERQUEIRA Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2012
Decision Date	11/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review