Device Dossier

Runway guide catheter - Catheter, intravascular, guiding

Device Dossier for Runway guide catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston Scientific).…

Intended purpose

For use in general intravascular, coronary and peripheral applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Functional description

The Runway guide catheter is designed to facilitate delivery of medical devices. The proximal end has a hub and luer to allow connection to complementary medical devices. The inner diameter is designed to facilitate passage of them. The shaft is reinforced for improved kink resistance and torque and is radiopaque. Distal shaft is designed to allow active engagement of catheter in ostium of artery. Tip has a reinforced segment for tip stability.

TGA Public Summary