Device Dossier

FlowGate 2 Balloon Guide Catheter - Catheter, intravascular, occluding

Device Dossier for FlowGate 2 Balloon Guide Catheter - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor…

Intended purpose

FlowGate 2 Balloon Guide Catheters are intended for use in facilitating the insertion and guidance of an intravascular catheter into a blood vessel in the neurovascular system, providing temporary vascular occlusion, and serving as a conduit for Retrieval devices.

Functional description

A coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is flush mounted on the distal end.

TGA Public Summary