HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER - -Ex

• • Terminated Z-0171-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006

  There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.

510(k) Number

K041726 ↗

FDA Product Code

KDI

Models / Variants

Aps-R

-M

-S

-E

-Ex

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Modified Sepacell Pl-Series Leukocyte Removal Filt

  Class II

  FDA 510(k) K896664 Active Cleared 24 Jan 1990

• Asahi AM-R Series Dialyzers

  Class II

  FDA 510(k) K970650 Active Cleared 30 Sep 1997

• Asahi Hollow Fiber Kidneys, Excel

  Class II

  FDA 510(k) K833150 Active Cleared 15 Nov 1983

• Asahi New Pan-Series Hemofilters

  Class II

  FDA 510(k) K844663 Active Cleared 18 Jan 1985

• Modified Am-Series Dialyzers

  Class II

  FDA 510(k) K854575 Active Cleared 2 Dec 1985

• APS Series Dialyzers

  Class II

  FDA 510(k) K001250 Active Cleared 16 Aug 2000

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