Device Dossier

Asahi Tornus Support Catheter - Catheter, intravascular, guiding

Device Dossier for Asahi Tornus Support Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Bio-Excel).…

Intended purpose

the percutaneous, transluminal passage and placement of steerable guidewires and diagnostic/interventional devices within the vascular system to access discrete regions of the vasculature and for guidewire exchange.

Functional description

A tapered catheter with a platinum marker enabling clear visibility of the catheter tip under fluoroscopy, a main shaft, a polymer sleeve (to prevent leakage of blood) and a hub connector. The main shaft is a coreless stainless steel coil that contains 8 wires stranded within the coil laid in a clockwise manner. It has a lumen through which a guidewire is inserted.

TGA Public Summary