Device Dossier
COPERNIC - Catheter, intravascular, occluding
Device Dossier for COPERNIC - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor Balt). ARTG record, intended…
- GMDN category: Catheter, intravascular, occluding
Intended purpose
COPERNIC is a catheter equipped with a small balloon intended for the treatment of temporary occlusions or vessel spasms. The profile of the catheter with deflated balloon does not exceed 3F, it is recommended therefore for operations on smaller vessels.
Functional description
The COPERNIC catheter is a single tube catheter, on the distal tip of which a balloon has been welded. The balloon is made of a hyper compliant synthetic elastomer. This allows the balloon to easily shape itself to the anatomy of the artery. Both inflation and deflation of the balloon can be performed only when the guide comes out of the tip of the catheter. This device is supplied with a guidewire.