Device Dossier

Hi Torque TurnTrac Flex Guide Wire Fully Coated Tip - Catheter guide wire

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

Intended purpose

Intended to facilitate the delivery of catheter-based interventional devices during the following procedures: • Percutaneous transl uminal angioplasty (PTA) • Percutaneous transluminal coronary angiopla sty (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