Device Dossier

Occlutech Delivery Set - Cardiac occluder delivery kit

Device Dossier for Occlutech Delivery Set - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Life Systems Medical). ARTG…

Intended purpose

The Occlutech Delivery Set is intended for carrying out percutaneous, catheter-based interventions to deploy Occlutech implants into the heart or the vasculature. With the aid of the Occlutech Delivery Set, a compatible Occlutech implant can be passed through the vascular system to its intended site of implantation.

Functional description

Includes delivery sheath, Y-hemostasis valve, dilator and loader. The dilator is inserted into the delivery sheath and both passed over a previously positioned guide wire into position through the vasculature. The dilator is removed and a separately supplied cardiac occluder and pusher are threaded into the combined Y-hemostasis valve/loader which is then connected to the delivery sheath. After positioning and release of the occluder, the delivery system is withdrawn from the vascular system.

TGA Public Summary