Device Dossier

Guidion Rapid Exchange Guide Extension - Catheter, intravascular, guiding

Device Dossier for Guidion Rapid Exchange Guide Extension - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor KD &…

Intended purpose

Guidion catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.

Functional description

Guidion catheter is a single lumen rapid exchange catheter compatible with 5F;6F;7F and 8F guide catheters and may be placed over an exchange length or 180cm guide wire. The 150cm long device has a stainless steel shaft that is followed distally by a 25cm lumen section. It has a radiopaque distal end which for fluoroscopic visibility and 2 positioning marks (95cm and 105cm from the distal tip). The catheter has a proximal hub indicating compatibility.

TGA Public Summary