FDA 510(k) Application Details - K122612

Device Classification Name	Graft, Vascular, Synthetic/Biologic Composite   More FDA Info for this Device
510(K) Number	K122612
Device Name	Graft, Vascular, Synthetic/Biologic Composite
Applicant	MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	MARYLOU INSINGA Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	MAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2012
Decision Date	09/10/2012
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