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510(k) K192413

SiteSeal Femoral Compression Device by Ensite Vacular, LLC — Product Code DXC

K192413 is an FDA 510(k) premarket notification submitted by Ensite Vacular, LLC for the device "SiteSeal Femoral Compression Device". The FDA issued a decision of Substantially Equivalent on March 31, 2020. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2020
Date Received
September 4, 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

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FDA data resources