510(k) K190351

Site Seal SV by Ensite Vascular — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2019
Date Received
February 14, 2019
Clearance Type
Traditional
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