Device Dossier

OptiSite Arterial Perfusion Cannula - Cannula, arterial

Device Dossier for OptiSite Arterial Perfusion Cannula - Cannula, arterial (Cannula, arterial, Class III, sponsor Device Technologies). ARTG record,…

Intended purpose

The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for < 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Functional description

The OptiSite Arterial Cannula has a smoothly rounded tip to facilitate atraumatic insertion and a blunt tip introducer with guidewire. The proximal ends of the cannulae are designed to accept 3/8" (9.5mm) tubing. Introducers are designed for use with 0.038” (0.96mm) guidewires. Each introducer is provided with a removable vented luer cap. Leave the vented cap in place to allow venting of the cannula for use without a guidewire. Remove the cap to allow cannula use with a guidewire.

TGA Public Summary