Device Dossier

Thin-Flex Single Stage Venous Drainage Cannula - Cannula, venous

Device Dossier for Thin-Flex Single Stage Venous Drainage Cannula - Cannula, venous (Cannula, venous, Class III, sponsor Device Technologies). ARTG…

Intended purpose

Venous return cannulae are specially intended to be used in cardiopulmonary bypass surgery in the context of a heart defect. They are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of ≤ 6 hours to replace heart function. A cardiopulmonary bypass circuit is created to establish circulation, and the arterial cannulae are parts of the essential elements of the circuit.