Device Dossier
Transend 300 - Catheter guide wire
Device Dossier for Transend 300 - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Stryker). ARTG record,…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
- Sponsor: Stryker
Intended purpose
The Transend 300 guidewires are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewire to facilitate directional manipulation of the guidewire.
Functional description
The Transend 300 guidewires are steerable guidewires available in a nominal diameter of 0.014 in (0.36 mm) and a length of 300 cm. The outer diameter may reach up to 0.0145 in (0.37 mm). The distal 2 cm are shapeable. The proximal portion of the guidewire is coated with PTFE. All guidewires have a core wire and an ICE hydrophilic coated surface to provide lubricity. The distal 3 cm tip of the wire is jacketed with a platinum coil to provide radiopacity.