Device Dossier

Distal Access Catheter - Catheter, intravascular, guiding

Device Dossier for Distal Access Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Stryker). ARTG record,…

Intended purpose

The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate distal access catheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may be used as a diagnostic angiographic catheter. It is also indicated for the removal/aspiration of fresh, soft emboli and thrombi from vessels in the arterial system, including the neurovasculature.

Functional description

The DAC is a single lumen braided shaft variable stiffness catheter with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.

TGA Public Summary