FDA 510(k)

V.A.C.ULTA Negative Pressure Wound Therapy System

N.º K: K162790 · 2017-01-26

SolicitanteKci USA, Inc. (Kinetic Concepts, Inc.)

Fecha de decisión2017-01-26

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

V.A.C.ULTA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K162790. 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 V.A.C.ULTA Negative Pressure Wound Therapy System?

V.A.C.ULTA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K162790.

When did V.A.C.ULTA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-01-26, under 510(k) number K162790.

Who is the listed applicant for V.A.C.ULTA Negative Pressure Wound Therapy System?

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

What is the FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System is OMP.

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Otros registros que enlistan a Kci USA, Inc. (Kinetic Concepts, Inc.) como solicitante

K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

Dispositivos relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.