FDA 510(k)

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

N.º K: K232803 · 2024-03-14

Fecha de decisión2024-03-14

Código de productoKDI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232803. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K232803.

When did NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) receive FDA 510(k) clearance?

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232803.

Who is the listed applicant for NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

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

What is the FDA product code for NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

The FDA product code for NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is KDI.

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Otros registros que enlistan a Nxstage Medical, Inc. como solicitante

K233213NxStage PureFlow Solution K230632VersiHD with GuideMe software K183158NxStage Cartridge Express with Speedswap K181991NxStage Connected Health System K171331NxStage System One K170469NxStage System One Plus

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Dispositivos relacionados (Código: 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

Fuente oficial

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