Scepter C Occlusion Balloon Catheter - Catheter, intravascular, occluding

Intended purpose

The Scepter Occlusion Balloon Catheter is intended for use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms. Intended for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. It is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

Functional description

The device is a coaxial balloon catheter with an inner lumen for a guidewire and an outer lumen for inflation and deflation of the balloon. The balloon catheter is compatible with 0.36 mm or smaller guidewires and can be inflated and deflated independently of guidewire position. The balloon catheter is available in different sizes and incorporates radiopaque markers to facilitate fluoroscopic visualization and a distal purge hole to purge air from the catheter prior to use. For single use only.