FDA 510(k) Application Details - K012041

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K012041
Device Name	Clamp, Vascular
Applicant	TENACORE HOLDINGS, INC. 23266 VIA RONDA MISSION VIEJO,, CA 92691 US Other 510(k) Applications for this Company
Contact	Brand Caso 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	06/29/2001
Decision Date	03/28/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review