Device Dossier

Marksman Catheter - Catheter, intravascular, stent-placement

Device Dossier for Marksman Catheter - Catheter, intravascular, stent-placement (Catheter, intravascular, guiding, Class III, sponsor Medtronic). ARTG…

Intended purpose

Intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents, into the neuro, peripheral and coronary vasculature.

Functional description

The device is a variable stiffness, single lumen catheter designed to access small tortuous vascular areas. The outer surface of the catheter's distal segment is coated with hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement or introduction devices passed through its lumen. The catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualisation. The distal tip of the catheter is shapeable.

TGA Public Summary