FDA 510(k) Application Details - K173563

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K173563
Device Name	Clamp, Vascular
Applicant	TZ Medical Inc 17750 SW Upper Boones Ferry Rd #150 Portland, OR 97224 US Other 510(k) Applications for this Company
Contact	John Lubisich 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	11/17/2017
Decision Date	01/10/2018
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