Device Dossier

Mach1 guide catheter - Catheter, intravascular, guiding

Device Dossier for Mach1 guide catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston Scientific). ARTG…

Intended purpose

Used to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. Intended for use in general intravascular, peripheral and coronary applications.

Functional description

The guide catheter proximal end has a hub and luer to allow strain relief and connection to complementary medical devices. The shaft consists of 3 layers. Catheter tip is composed of a reinforced proximal part and non-reinforced distal end to minimise vascular trauma.

TGA Public Summary