Device Dossier
X-pedion Hydrophilic Guidewire - Catheter guide wire
Device Dossier for X-pedion Hydrophilic Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…
- 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 aiding selective positioning of the catheter in general intervascular use, and/or in peripheral, visceral and cerebral vasculature during diagnostic and /or therapeutic procedures. It is typically made of stainless steel, with a hydrophilic coating (coating facilitates its movement). This device is single-use.
Functional description
A guidewire wiht a soft flexible tip that provides robust support for navigation and aids selective placment of "Hyper" family balloons and ev3 branded over wire microcatheters. It is designed to enter the vascular percutaneously via an introducer needle (provided sterile as part of system)to provide atraumatic access to distal vessels of AVM and other diseased vasculature. Included within the guidewire sterile pouch is a Torque device to assist in guidewire manipulation.