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Hemodialyzer With Expanded Solute Removal Profile

FDA product code QAX · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5862
Review panel
GU
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2026-07-28 – 2026-07-28

A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa).

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