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FDA 510(k)

Site Seal SV

K-Number: K190351 · 2019-07-02

ApplicantEnsite Vascular
Decision Date2019-07-02
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Site Seal SV is a medical device manufactured by Ensite Vascular. It received FDA 510(k) clearance on 2019-07-02 under approval number K190351. 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 Site Seal SV?

Site Seal SV is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Ensite Vascular. The 510(k) number is K190351.

When was Site Seal SV approved by the FDA?

Site Seal SV received FDA 510(k) clearance on 2019-07-02, under approval number K190351.

What company makes Site Seal SV?

Site Seal SV is manufactured by Ensite Vascular.

What is the FDA product code for Site Seal SV?

The FDA product code for Site Seal SV is DXC.

Other Devices by Ensite Vascular

K210681SiteSeal 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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