Device Dossier

Biliary stone retrieval balloon catheter

Device Dossier for Biliary stone retrieval balloon catheter (Biliary stone retrieval balloon catheter, Class IIa, sponsor Device Technologies). ARTG…

Intended purpose

A flexible, tubular, manual endotherapy device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi). It is inserted through the working channel of an endoscope, typically beyond the stones where the balloon is inflated and retracted, the balloon pushing the trapped stones out. It typically has more than one lumen to allow,.e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium.

TGA Public Summary