FDA 510(k)

Cycler Drain Bag Set

Número K: K173363 · 2018-01-24

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2018-01-24

Código do produtoKDJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Fresenius Medical Care Renal Therapies Group, LLC como candidato(a)

K261267Careflux H60;Careflux H70;Careflux V500 K252377NxStage System One with NxView K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)K253518FX CorAL 40; FX CorAL 50 K250634BCM2-Body Composition Monitor

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Dispositivos Relacionados (Código: KDJ)

Fonte oficial

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