Device Dossier

Nitrex™ guidewire - Catheter guide wire

Device Dossier for Nitrex™ guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Medtronic). ARTG…

Intended purpose

The 0.014 in. (0.36 mm) and 0.018 in. (0.46 mm) diameter NITREX Nitinol Guidewires are intended for use in the peripheral and coronary vasculature.

Functional description

The Nitrex™ nitinol guidewire is constructed of a nitinol core wire with a gold-plated tungsten coil. The wire has a proprietary silicone coating for ease in guidewire placement. A torque device is packaged with 0.014 in. (0.36 mm) through 0.018 in. (0.46 mm) diameter Nitrex nitinol guidewires.

TGA Public Summary