# K980600: D903 Avant Adult Hollow Fiber Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Dideco S.P.A.
- Decided: Aug 12, 1998 after 176 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922933 (1992). 1 ancestor in all.
73 later devices descend from it; 2 cite it directly.
3 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922933: Sorin Monolyrh Integrated Membrane Lung, Sorin Biomedica, Fiat, USA, Inc. (1992) Summary page 3.

## Most influential descendants
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator (2002), 72 descendants of its own
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy (2002), 35 descendants of its own
- K031223: Synthesis Mimesys Adult Membrane Oxygenator (2003), 32 descendants of its own
- K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating (2004), 28 descendants of its own
- K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi (2008), 27 descendants of its own

## Indications for use
The Dideco D903 Avant Hollow Fiber Oxygenator 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 patients’ veins during normal operation to assure the proper oxygenation capability of the device. The D903 Avant is intended to be used for six hours or less.

Source page: https://510kreport.com/device/K980600
Methodology: https://510kreport.com/methodology