FDA 510(k)

SiteSeal Femoral Compression Device

Número K: K192413 · 2020-03-31

Data da decisão2020-03-31

Código do produtoDXC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SiteSeal Femoral Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Ensite Vacular, LLC. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K192413. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SiteSeal Femoral Compression Device?

SiteSeal Femoral Compression Device is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Ensite Vacular, LLC. The 510(k) number is K192413.

When did SiteSeal Femoral Compression Device receive FDA 510(k) clearance?

SiteSeal Femoral Compression Device received FDA 510(k) clearance on 2020-03-31, under 510(k) number K192413.

Who is the listed applicant for SiteSeal Femoral Compression Device?

The FDA 510(k) record lists Ensite Vacular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SiteSeal Femoral Compression Device?

The FDA product code for SiteSeal Femoral Compression Device is DXC.

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