Device Dossier

Guidewire SFC-400/6-018/Niti-Pt 400 cm, 0.018'' - Catheter guide wire

Device Dossier for Guidewire SFC-400/6-018/Niti-Pt 400 cm, 0.018'' - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III,…

Intended purpose

Guide wires are intended to be placed in the human body invasively or surgically-invasively through a natural or artificially produced body orifice or minimally-invasively through a port in the blood vessels of the central circulatory system, to be guided by controllable distal and proximal ends to a certain area of the human body to be used as a guide for catheters or other medical devices which are intended to be used in this area of the body.

Functional description

Nitinol guide wire with flexible radiopaque platinum coil distal, PTFE coated, single in dispenser with introducer, luer and J-tip protector, sterile.

TGA Public Summary