Device Dossier
SOFIA EX Catheter - Catheter, intravascular, guiding
Device Dossier for SOFIA EX Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Life Healthcare). ARTG…
- GMDN category: Catheter, intravascular, guiding
Intended purpose
The SOFIA EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
Functional description
The SOFIA EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65 cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.