FDA 510(k)

Машина_для_диализа_AK_98_(955607)

Номер K: K250508 · 2025-08-01

Дата решения2025-08-01

Код продуктаKDI

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

AK 98 Dialysis Machine (955607) is the device name listed in this FDA 510(k) record. The listed applicant is Vantive US Healthcare, LLC. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250508. 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 AK 98 Dialysis Machine (955607)?

AK 98 Dialysis Machine (955607) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Vantive US Healthcare, LLC. The 510(k) number is K250508.

When did AK 98 Dialysis Machine (955607) receive FDA 510(k) clearance?

AK 98 Dialysis Machine (955607) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250508.

Who is the listed applicant for AK 98 Dialysis Machine (955607)?

The FDA 510(k) record lists Vantive US Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK 98 Dialysis Machine (955607)?

The FDA product code for AK 98 Dialysis Machine (955607) 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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