Apex Adult Hollowe Fiber Oxygenator

• • Terminated Z-0760-2012 FDA Unclassified (pre-2012) ·initiated 2 Dec 2011

  Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.

510(k) Number

K014080 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dideco Electa Autotransfusion Apparatus

  Class II

  FDA 510(k) K020647 Active Cleared 5 Sep 2002

• Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy

  Class II

  FDA 510(k) K022450 Active Cleared 22 Oct 2002

• Dhf 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; Dhr 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult

  Class II

  FDA 510(k) K021732 Active Cleared 4 Nov 2002

• Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator

  Class II

  FDA 510(k) K032040 Active Cleared 9 Jul 2003

• D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.i.s.i.o. Adult Hollow Fiber Oxygenator with Coating

  Class II

  FDA 510(k) K033323 Active Cleared 13 Jan 2004

• D902 Ph.i.s.i.o Oxygenator; D920 Ph.i.s.i.o Reservoir; Dideco D736 Ph.i.s.i.o Filter

  Class II

  FDA 510(k) K013915 Active Cleared 27 Dec 2001

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