Dialysate Concentrate for Hemodialysis-Liquid/Powd

• • Terminated Z-1859-2021 FDA Class II ·initiated 20 Apr 2021

  The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

510(k) Number

K843963 ↗

FDA Product Code

FKQ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K833622 Active Cleared 29 Nov 1983

• Primus Hollow Fiber Dialyzer (Models 1000, 1000S, 1350, 1350S, 2000, 2000S)

  Class II

  FDA 510(k) K970648 Active Cleared 5 Jan 1998

• Hemasite Graftless Vascular Acess

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  FDA 510(k) K812890 Active Cleared 16 Nov 1981

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• Renaflo II

  Class II

  FDA 510(k) K823546 Active Cleared 16 Dec 1982

• Renal Systems Hemodialysis Concentrate

  Class II

  FDA 510(k) K792213 Active Cleared 4 Jan 1980

See all devices from Renal Systems, Inc. →