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 intended for cannula drainage from the superior and inferior vena cava during extracorporeal circulation for a duration of < 6 hours. Venous return cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patients. The 40 Fr. (13.3 mm) wire reinforced venous return cannula is also indicated for single tube venous drainage from the right atrium.

Functional description

Edwards Lifesciences Single Stage Venous Drainage cannulae are single-use disposable devices that are intended for drainage from the superior and inferior vena cava during short- term (<6 hours) cardiopulmonary bypass procedures.

TGA Public Summary