Device Dossier

Equalizer Occlusion Balloon Catheter - Catheter, intravascular, occluding

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

Intended purpose

The Equalizer Occlusion Balloon Catheter is indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures in the peripheral vasculature and the descending aorta.

Functional description

Equalizer balloon catheter is designed for temporary occlusion of vessels up to 40mm in diameter. To allow for large inflation diameters, the balloons are mounted on a non-tapered catheter shaft. The Catheter has two marked lumens, one for the balloon inflation and the other marked distal for the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire and can also be used for infusion of contrast medium & therapeutic drugs.

TGA Public Summary