FDA 510(k)

VasoStat Hemostasis Device

N.º K: K153259 · 2016-01-06

Fecha de decisión2016-01-06

Código de productoDXC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VasoStat Hemostasis Device is the device name listed in this FDA 510(k) record. The listed applicant is Forge Medical, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K153259. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VasoStat Hemostasis Device?

VasoStat Hemostasis Device is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Forge Medical, Inc.. The 510(k) number is K153259.

When did VasoStat Hemostasis Device receive FDA 510(k) clearance?

VasoStat Hemostasis Device received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153259.

Who is the listed applicant for VasoStat Hemostasis Device?

The FDA 510(k) record lists Forge Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VasoStat Hemostasis Device?

The FDA product code for VasoStat Hemostasis Device is DXC.

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Fuente oficial

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