FDA 510(k)

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

N.º K: K160451 · 2016-06-20

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

Fecha de decisión2016-06-20

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... 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 2016-06-20 under 510(k) number K160451. 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. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K160451.

When did V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... receive FDA 510(k) clearance?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160451.

Who is the listed applicant for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

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. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

The FDA product code for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is OMP.

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

K162790V.A.C.ULTA Negative Pressure Wound Therapy System K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

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

Ver en la base de datos de la FDA →

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