Device Dossier
Catheter, bronchial balloon
Device Dossier for Catheter, bronchial balloon (Catheter, bronchial balloon, Class IIa, sponsor PulmonX). ARTG record, intended purpose, GMDN category —…
- GMDN category: Catheter, bronchial balloon
Intended purpose
A catheter with an inflatable balloon at its distal end to be used with the Chartis Console during a diagnostic bronchoscopy in adult patients with chronic obstructive pulmonary disease and emphysema. The system is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments.