# K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating

- Pathway: 510(k) (Abbreviated)
- Applicant: Dideco S.P.A.
- Decided: Jan 13, 2004 after 90 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922933 (1992). 5 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980600: D903 Avant Adult Hollow Fiber Oxygenator, Dideco S.P.A. (1998) Summary page 1.
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator, Dideco S.P.A. (2002) Summary page 1.
- K004001: Monolyth Mimesys Hollow Fiber Oxygenator, Dideco (2001) Summary page 1.

## Most influential descendants
- K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (2005), 17 descendants of its own
- K121229: Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/Cardiotomy (2012), 12 descendants of its own
- K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir (2012), 10 descendants of its own
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior (2012), 8 descendants of its own
- K122254: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (2012), 6 descendants of its own

## Recalls of this device
- Dec 2, 2011 · Not classified · Z-0766-2012: 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-

## Indications for use
The Dideco D 903 Avant Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

Source page: https://510kreport.com/device/K033323
Methodology: https://510kreport.com/methodology