Am-Bio Extended Range Series Dialyzer, Models Wet and Dry

• • Terminated Z-0789-05 FDA Unclassified (pre-2012) ·initiated 31 Mar 2005

  Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

510(k) Number

K013418 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K041726 Active Cleared 23 Jul 2004

• Modified Am-Series Dialyzers

  Class II

  FDA 510(k) K854575 Active Cleared 2 Dec 1985

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