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

• • Terminated Z-0766-2012 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

K033323 ↗

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

• 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

• Mvr 1200 Pc: Sorin Monolyth Venous Reservoir 1200 Pc with Phosphorylcholine Coating

  Class II

  FDA 510(k) K033714 Active Cleared 11 Dec 2003

See all devices from Dideco S.P.A. →

• What is the primary function of the D 903 Avant oxygenator?

  The D 903 Avant and D 903 Avant 2 Ph.i.s.i.o. are designed for use during cardiopulmonary bypass surgery. They provide essential oxygenation and carbon dioxide removal from venous blood while incorporating a heat exchanger to manage blood temperature during extracorporeal circulation.

• What is the difference between the D 903 Avant and the D 903 Avant 2 Ph.i.s.i.o. models?

  Both models serve the same clinical purpose for adult extracorporeal circulation. The D 903 Avant 2 Ph.i.s.i.o. specifically features a coating, whereas the standard D 903 Avant does not include this specification.

• What is the regulatory status of these oxygenators?

  These devices are authorized for use under FDA 510(k) clearance. This indicates that the devices have been reviewed and found to be substantially equivalent to legally marketed predicate devices for their intended use in clinical settings.