Device Dossier
Smart Port CT - Vascular port/catheter
Device Dossier for Smart Port CT - Vascular port/catheter (Vascular port/catheter, Class III, sponsor Medical Specialties). ARTG record, intended…
- GMDN category: Vascular port/catheter
Intended purpose
The Smart Port CT 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 CT device consists of a titanium port (with a self-sealing silicone septum) and a silicone radiopaque catheter. Kit components required for the surgical implantation of the device are also included. Access is performed by percutaneous insertion using non-coring needle. Implantable access device for administration of medications, fluids, contrast media etc and for blood sampling.