Device Dossier

BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding

Device Dossier for BOBBY Balloon Guide Catheter - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor Life…

Intended purpose

The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also intended for use as a conduit for retrieval devices.

Functional description

The BOBBY Balloon Guide Catheter is a dual lumen catheter with an external hydrophilic coating. The balloon guide catheter incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use.

TGA Public Summary