Device Dossier
Hi-Torque VersaTurn Guide Wire - Fully Coated - Catheter guide wire
Device Dossier for Hi-Torque VersaTurn Guide Wire - Fully Coated - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III,…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
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) VersaTurn devices are 0.014” steerable guide wires offered in several configurations with varying support level, tip load, 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. There are 48 configurations which include 4 tip loads, 3 support levels, 2 tip shapes and 2 lengths.