Device Dossier

Element Vascular Access System - Catheter, intravascular, guiding

Device Dossier for Element Vascular Access System - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Penumbra…

Intended purpose

The Element Vascular Access System is intended to provide a conduit for introduction of interventional devices to the peripheral anatomy.

Functional description

The Element Vascular Access System includes an Element Sheath and a Dilator. The Element Sheath is a single lumen, variable stiffness sheath with a radiopaque markerband on the distal end and a Valve System on the proximal end. The Dilator is a single lumen, radiopaque catheter with a tapered distal end and a Luer hub on the proximal end. The Element Vascular Access System should be used with a 0.038 in [0.97 mm] guidewire to access the desired anatomy.

TGA Public Summary