Device Dossier

Smart Port CT Low-Profile - Vascular port/catheter

Device Dossier for Smart Port CT Low-Profile - Vascular port/catheter (Vascular port/catheter, Class III, sponsor Medical Specialties). ARTG record,…

Intended purpose

The Smart Port CT Low-Profile power injectable port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, sampling of blood and power injection of contrast media for imaging.

Functional description

The Smart Port is an implantable venous port designed for power injection. The Smart Port as a functional unit consists of a small chamber (port housing) with radiopaque catheter. The port is sealed at the top with a self-sealing injection septum. The port body is surgically implanted in a subcutaneous pocket. The Smart Port includes a complete percutaneous introducer set for surgical implantation. The port is accessed by inserting a non-coring needle (huber needle) into the port septum.

TGA Public Summary