Device Dossier

Catheter, gastrointestinal balloon

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

Intended purpose

A thin, flexible tube with an inflatable balloon at its distal tip typically used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, or colon. The balloon is inflated to its prescribed diameter (typically between 6 millimetre (mm) and 20 mm) to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type.This is used in conjunction with an ultrasonic endoscope for diagnosis and treatment in the gastrointensinal and brochial tract.

TGA Public Summary