Device Dossier

Fighter™ Guidewire – Straight Tip - Catheter guide wire

Device Dossier for Fighter™ Guidewire – Straight Tip - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston…

Intended purpose

Intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices.

Functional description

Fighter Guidewires with hydrophilic coating are steerable guidewires available with a nominal diameter of 0.014in (≤0.37mm) & in nominal lengths of 190cm or 300cm. The proximal section of the guidewires is PTFE coated. The 190cm guidewires are designed with a 2.1cm friction fit extension section for exchange of Over-the-Wire systems by using the Stretch Extension Wire. The 300cm guidewire allows exchange of devices without the use of an extension wire or exchange system

TGA Public Summary