Fresenius Hemoflow F3, F4, F5, F7

• • Terminated Z-1324-2016 FDA Class II ·initiated 26 Feb 2016

  Dialyzer header leak due to possible improper torque

510(k) Number

K874872 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Drs-4 Dialyzer Reprocessing System

  Class II

  FDA 510(k) K914580 Active Cleared 24 Feb 1992

• Dps 4 Dialyzer Preparation System

  Class II

  FDA 510(k) K955299 Active Cleared 21 Oct 1996

• Fresenius Hemoflow F6 and F8

  Class II

  FDA 510(k) K870725 Active Cleared 1 May 1987

• Dialyzer Reprocessing System Drs-4

  Class II

  FDA 510(k) K821863 Active Cleared 18 Oct 1982

• Fresenius Hemodialysis Machine A1008 Bsm

  Class II

  FDA 510(k) K855001 Active Cleared 21 Jan 1986

• Fresenius Hemoflow F60 and F80

  Class II

  FDA 510(k) K870724 Active Cleared 1 Apr 1987

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