FDA 510(k)

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

Номер K: K210575 · 2022-05-13

ЗаявительNephros

Дата решения2022-05-13

Код продуктаKDI

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210575. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Nephros. The 510(k) number is K210575.

When did HDF Assist Mudule, HDF Infusion Set and Substitution Filter receive FDA 510(k) clearance?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210575.

Who is the listed applicant for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

The FDA 510(k) record lists Nephros as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

The FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter is KDI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Официальный источник

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