FDA 510(k) Application Details - K192413

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K192413
Device Name	Clamp, Vascular
Applicant	Ensite Vacular, LLC 10900 South Clay Blair Blvd, Suite 800 Olathe, KS 66061 US Other 510(k) Applications for this Company
Contact	Tom Reidy 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	09/04/2019
Decision Date	03/31/2020
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