FDA 510(k)

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Número K: K222067 · 2022-11-10

RequerenteQuanta Dialysis Technologies, Ltd.

Data da decisão2022-11-10

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K222067. 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 SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K222067.

When did SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set receive FDA 510(k) clearance?

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222067.

Who is the listed applicant for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA 510(k) record lists Quanta Dialysis Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA product code for SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set is KDI.

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Outros registros que listam Quanta Dialysis Technologies, Ltd. como candidato(a)

K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

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

Fonte oficial

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