FDA 510(k)

Cycler Drain Bag Set

N.º K: K173363 · 2018-01-24

SolicitanteFresenius Medical Care Renal Therapies Group, LLC

Fecha de decisión2018-01-24

Código de productoKDJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cycler Drain Bag Set is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2018-01-24 under 510(k) number K173363. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cycler Drain Bag Set?

Cycler Drain Bag Set is a medical device that received FDA 510(k) clearance on 2018-01-24. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173363.

When did Cycler Drain Bag Set receive FDA 510(k) clearance?

Cycler Drain Bag Set received FDA 510(k) clearance on 2018-01-24, under 510(k) number K173363.

Who is the listed applicant for Cycler Drain Bag Set?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cycler Drain Bag Set?

The FDA product code for Cycler Drain Bag Set is KDJ.

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Otros registros que enlistan a Fresenius Medical Care Renal Therapies Group, LLC como solicitante

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Dispositivos relacionados (Código: KDJ)

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.