Device Dossier
FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
Device Dossier for FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Life…
- GMDN category: Stent, vascular, intracranial
Intended purpose
The FRED X System is intended for endovascular embolization of intracranial neurovascular aneurysms. The FRED X System may also be used with embolic coils for the treatment of intracranial neurovascular lesions.
Functional description
The FRED X System includes: A self-expanding, single wire braid, closed-cell, surface treated nitinol stent. An integrated dual layer construct designed to focus mainly at the neck of an aneurysm. Radiopaque markers on its proximal and distal ends as well as interwoven helical marker strands delineating the inner working length of the stent to provide fluoroscopic visibility.