Device Dossier
Transend 0.010 - Catheter guide wire
Device Dossier for Transend 0.010 - 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 0.010 guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is 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 0.010 guidewire is a steerable guidewire available in a nominal diameter of 0.010 in (0.26 mm), and a nominal length of 205 cm. The distal 61 cm of the guidewire contains a core wire that is jacketed with a radiopaque polymer and is coated with a hydrophilic coating to provide lubricity. The distal 2 cm of the guidewire is shapeable. The proximal portion of the guidewire is coated with PTFE.