Device Dossier

Bridge Occlusion Balloon Catheter - Catheter, intravascular, occluding

Device Dossier for Bridge Occlusion Balloon Catheter - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor Life…

Intended purpose

The Bridge Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Functional description

A compliant balloon mounted on a multi-lumen non-tapered catheter shaft connected to a proximal hub. Radiopaque markers placed within the balloon segment of the catheter provide visual reference points for balloon positioning within the vessel. The hub port, marked BALLOON, is connected to the balloon inflation Iumen. The unmarked hub port is connected to the central Iumen of the catheter, which terminates at the distal tip. This Iumen is used to pass the catheter over a guidewire.

TGA Public Summary