Device Dossier

Hi-Torque TurnTrac Guide Wire Uncoated Tip - Catheter guide wire

Device Dossier for Hi-Torque TurnTrac Guide Wire Uncoated Tip - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III,…

Intended purpose

Intended to facilitate the delivery of catheter-based interventional devices during the following procedures: • Percutaneous transluminal angioplasty (PTA) • Percutaneous transluminal coronary angioplasty (PTCA) This guide wire may also be used with compatible stent devices.

Functional description

The HI-TORQUE (HT) TurnTrac devices are 0.014” steerable guide wires offered in several configurations with varying support level, tip load, hydrophilic coating length, tip shape and guide wire length. They also have a hydrophilic coating on the distal end and a hydrophobic coating on the proximal section. The distal tip has a radiopaque length of 3.0 cm.

TGA Public Summary