Device Dossier

Headway Duo Microcatheter - Catheter, intravascular, guiding

Device Dossier for Headway Duo Microcatheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Life Healthcare).…

Intended purpose

The Headway Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. The Headway Duo Microcatheter is intended for neurovascular use, for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.

Functional description

A single lumen catheter to be introduced over a steerable guidewire to access small, tortuous vasculature. Semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface is coated with a hydrophilic coating to reduce friction during navigation and a luer fitting on the microcatheter hub is used for theis used for the attachment of accessories.

TGA Public Summary