FDA 510(k)

Careflux H60;Careflux H70;Careflux V500

Número K: K261267 · 2026-07-24

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2026-07-24

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Careflux H60;Careflux H70;Careflux V500 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 2026-07-24 under 510(k) number K261267. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Careflux H60;Careflux H70;Careflux V500?

Careflux H60;Careflux H70;Careflux V500 is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K261267.

When did Careflux H60;Careflux H70;Careflux V500 receive FDA 510(k) clearance?

Careflux H60;Careflux H70;Careflux V500 received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261267.

Who is the listed applicant for Careflux H60;Careflux H70;Careflux V500?

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 Careflux H60;Careflux H70;Careflux V500?

The FDA product code for Careflux H60;Careflux H70;Careflux V500 is KDI.

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Dispositivos Relacionados (Código: KDI)

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Fonte oficial

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