Device Dossier

HyperGlide Occlusion Balloon Catheter System - Catheter, intravascular, occluding

Device Dossier for HyperGlide Occlusion Balloon Catheter System - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III,…

Intended purpose

For use in the blood vessels where temporary occlusion is desired. The Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow.

Functional description

Single lumen balloon catheter that requires the insertion of a guidewire (included with the catheter) to occlude the central lumen to allow inflation of the balloon. When the distal 10cm coil tip of the guidewire is advanced to or past the catheter tip, it occludes the inflation holes allowing the balloon to inflate through catheter sideholes.

TGA Public Summary