Device Dossier

FreeClimb 88 with Tenzing 8 Access System - Catheter, intravascular, guiding

Device Dossier for FreeClimb 88 with Tenzing 8 Access System - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

The Route 92 Medical FreeClimb Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Functional description

The Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by two radiopaque markers. The proximal end has a luer hub. The Delivery Catheter is only for use with the Support Catheter. The Support Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The distal 65 cm of the Support Catheter and distal 90 cm of the Delivery Catheter are hydrophilically coated to provide lubricity and facilitate movement.

TGA Public Summary