Device Dossier
087 Balloon Guide Catheter System - Catheter, intravascular, occluding
Device Dossier for 087 Balloon Guide Catheter System - Catheter, intravascular, occluding (Catheter, intravascular, occluding, Class III, sponsor Device…
- GMDN category: Catheter, intravascular, occluding
- Sponsor: Device Technologies
Intended purpose
A Balloon Guide Catheter System intended to be placed in the internal carotid artery (ICA), facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The device is also indicated for use as a conduit for retrieval devices.
Functional description
A variable stiffness catheter utilising a bifurcated dual port luer hub on the proximal end. The central port facilitates the introduction of interventional devices and inflation port facilitates inflating and deflating of the balloon. The catheter has dual radiopaque distal marker bands on each side of the balloon. The distal balloon provides expandable means to contact the vessel wall and arrest flow as the clot is being removed.