Device Dossier

FreeClimb 88 Reperfusion Catheter with Tenzing 8 - Embolectomy/thrombectomy suction catheter

Device Dossier for FreeClimb 88 Reperfusion Catheter with Tenzing 8 - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction…

Intended purpose

The Route 92 Medical FreeClimb 88 Reperfusion System is intended for use in the introduction of interventional devices into the neurovasculature and for aspiration of thrombus in ischemic stroke patients.

Functional description

Delivery Catheter is single-lumen with variable stiffness and a long, tapered tip delineated by two radiopaque markers; the proximal end has a luer hub and is designed specifically for use with the Aspiration Catheter. Aspiration Catheter is single-lumen with variable stiffness and has a radiopaque marker at the distal tip. Both catheters have a hydrophilic coating to facilitate movement.

TGA Public Summary