FDA 510(k) Application Details - K210681

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K210681
Device Name	Clamp, Vascular
Applicant	Ensite Vascular 10900 S. Clay Blair Blvd. Olathe, KS 66061 US Other 510(k) Applications for this Company
Contact	Thomas 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	03/08/2021
Decision Date	04/06/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review