FDA 510(k)

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit

Numéro K : K173447 · 2018-03-02

Date de décision2018-03-02

Code produitOMP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173447. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit?

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Kci USA, Inc.. The 510(k) number is K173447.

When did V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit receive FDA 510(k) clearance?

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173447.

Who is the listed applicant for V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit?

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

What is the FDA product code for V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit?

The FDA product code for V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit is OMP.

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Source officielle

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