Device Dossier
Transend EX - Catheter guide wire
Device Dossier for Transend EX - 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 EX guidewires are 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 EX guidewires are steerable guidewires available in a nominal diameter of 0.014 in (0.36 mm), and nominal lengths of 182 cm and 205 cm. The distal 39 cm of the guidewires 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.