Device Dossier
Mirage Hydrophilic Guidewire - Catheter guide wire
Device Dossier for Mirage Hydrophilic Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Medtronic).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
A coiled wire that is designed to fit inside a percutaneous catheter for the purpose of selective positioning of the catheter in general intervascular use, and/or in the peripheral,visceral and cerebral vasculature during diagnostic and/or therapeutic procedures. It is typically made of stainless steel, with a hdrophilic coating (coating facilitates its movement). This device is single-use.
Functional description
A guidewire with a uniquely tapered profile (0.008" distal diameter)and soft coil tip designed to enter the vascular percutaneously via an introducer(provided sterile with the system) to provide atraumatic access to distal vessels of AVM and other diseased vasculature. It provides support for navigation of ev3 branded delivery microcatheters such as Marathon, Ultraflow, Apollo and Onyx. Included within the guidewire sterile pouch is a Torque device to assist in guidewire manipulation.