Device Dossier

Catheter, gastrointestinal balloon

Device Dossier for Catheter, gastrointestinal balloon (Catheter, gastrointestinal balloon, Class IIa, sponsor PlainSolution). ARTG record, intended…

Intended purpose

It is a thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, or colon. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. This is a single-use device.

TGA Public Summary