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FDA 510(k)

SiteSeal SV

K-Number: K210681 · 2021-04-06

ApplicantEnsite Vascular
Decision Date2021-04-06
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SiteSeal SV is a medical device manufactured by Ensite Vascular. It received FDA 510(k) clearance on 2021-04-06 under approval number K210681. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SiteSeal SV?

SiteSeal SV is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by Ensite Vascular. The 510(k) number is K210681.

When was SiteSeal SV approved by the FDA?

SiteSeal SV received FDA 510(k) clearance on 2021-04-06, under approval number K210681.

What company makes SiteSeal SV?

SiteSeal SV is manufactured by Ensite Vascular.

What is the FDA product code for SiteSeal SV?

The FDA product code for SiteSeal SV is DXC.

Other Devices by Ensite Vascular

K190351Site Seal SV

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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