Device Dossier

SelectSite Deflectable Catheter System - Catheterization kit, cardiac

Device Dossier for SelectSite Deflectable Catheter System - Catheterization kit, cardiac (Catheterization kit, cardiac, Class III, sponsor Medtronic).…

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

C304 delivery systems are composed of a single-use, disposable, deflectable catheter, dilator, guidewire, and slitter. A percutaneous needle and syringe may also be included in the package. 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