Device Dossier
Polysite with polyurethane catheter - Vascular port/catheter
Device Dossier for Polysite with polyurethane catheter - Vascular port/catheter (Vascular port/catheter, Class III, sponsor Device Technologies). ARTG…
- GMDN category: Vascular port/catheter
- Sponsor: Device Technologies
Intended purpose
A device intended to allow repeated and prolonged access to the venous system. The port is used to administer chemotherapy, antibiotics, antiviral, parenteral nutrition, transfusion of blood or blood products. The device can be used for high rate injection of contrast media during CT procedures.
Functional description
The Polysite implantable access port allows repeated and prolonged access to the vascular system. It consists of a radiopaque chamber and a radiopaque catheter, connected together and held together by a connecting ring. It is provided pre-connected or non-connected. Access to the chamber is done by placing a Huber needle through the septum. Includes accessories for implantation and access.