Modification to:fresenius 2008T Hemodialysis Machine, Model 190573

• • Terminated Z-0629-2014 FDA Class II ·initiated 12 Nov 2013

  2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup

• • Terminated Z-1693-2013 FDA Class II ·initiated 24 May 2013

  Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)

510(k) Number

K093902 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series Open recall

  Class II

  FDA 510(k) K070177 Active Cleared 29 Mar 2007

• Crit-Line Clip (Clic) Blood Chamber

  Class II

  FDA 510(k) K152953 Active Cleared 5 Nov 2015

• Optiflux dialyzer Open recall

  Class II

  FDA 510(k) K162488 Active Cleared 6 Apr 2017

• Fresenius Art Hemoadsorption System

  Unclassified

  FDA 510(k) K050273 Active Cleared 8 Jun 2005

• Frsenius Pd Iqcard Cycler

  Class II

  FDA 510(k) K002892 Active Cleared 5 Apr 2001

• Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

See all devices from Fresenius Medical Care North America →