FDA 510(k)

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System

N.º K: K173426 · 2018-03-09

Fecha de decisión2018-03-09

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System 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 2018-03-09 under 510(k) number K173426. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System?

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Kci USA, Inc.. The 510(k) number is K173426.

When did PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System receive FDA 510(k) clearance?

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173426.

Who is the listed applicant for PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System?

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 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System?

The FDA product code for PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System is OMP.

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Otros registros que enlistan a Kci USA, Inc. como solicitante

K2411343M™ ActiV.A.C.™ Cilindro - 300ml con Gel (M8275058/5, M8275058/10)K201571ACTIV.A.C. Negative Pressure Wound Therapy System K200390V.A.C. DERMATAC Drape K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)K181505V.A.C. DERMATAC Drape K183543ACTIV.A.C. Therapy Unit

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Fuente oficial

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