Device Category Dossier

Catheter, gastrointestinal balloon

Device Category Dossier for Catheter, gastrointestinal balloon. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Gastrointestinal balloon catheters are thin, flexible tubes with an inflatable balloon at the distal tip that are used endoscopically to dilate strictures by inflating the balloon to its prescribed diameter to widen the affected passage. These devices are used to treat strictures of the oesophagus, pylorus, colon, and gastro-oesophageal junction, particularly those resulting from surgery, gastro-oesophageal reflux disease, radiation therapy, or achalasia.