Device Dossier

Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding

Device Dossier for Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

This guide catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This guide catheter is not intended for use in cerebral vasculature and peripheral vasculature such as arms and legs.

Functional description

Asahi Hyperion guiding catheter consists of a "shaft", a "hub" for catheter control or drug infusion and for insertion of devices such as balloon catheter and a guide wire, and a "protector" that is a strain relief for the jointed catheter and the hub. The shaft has a mechanism with a braided wire embedded inside it as reinforcement so that rotation of proximal portion can be promptly transmitted to the distal tip.

TGA Public Summary