FDA 510(k) Application Details - K132175

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K132175
Device Name	Clamp, Vascular
Applicant	EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	LUKE MEIDELL 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	07/15/2013
Decision Date	09/13/2013
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