Device Dossier
True Form Reshapable Guide wire - Catheter guide wire
Device Dossier for True Form Reshapable Guide wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Merit…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures. The True Form Reshapable Guide Wire should not be used in the neurovasculature.
Functional description
True Form Reshapable Guide Wire are placed through a transcutaneous device and advanced to the desired location according to the planned procedure by clinicians. They are used to facilitate the placement of catheters within the peripheral and coronary vasculature during diagnostic and interventional procedures. Verification of guide wire placement is typically accomplished with fluoroscopy.