510(k) K210681

SiteSeal SV by Ensite Vascular — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2021
Date Received
March 8, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type