Device Dossier

SelectSite™ C304-HIS Deflectable catheter system - Catheter, intravascular, guiding

Device Dossier for SelectSite™ C304-HIS Deflectable catheter system - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III,…

Intended purpose

The delivery system is intended to support the placement of transvenous devices into the right chambers or coronary vasculature of the heart. After the intended location is accessed and the lead is delivered, the delivery system is removed.

Functional description

The C304-HIS delivery system is composed of a single-use, disposable, deflectable catheter with fixed distal curve, dilator, guidewire, and slitter. These components are used together to provide a flexible, hemostatic conduit for insertion of intravascular devices into the right chambers or the coronary vasculature of the heart.

TGA Public Summary