FDA 510(k) Application Details - K153523

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K153523
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	Mark Dinger Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2015
Decision Date	02/16/2016
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