Device Dossier

GORE® Tri-Lumen Catheter - Catheter, intravascular, guiding

Device Dossier for GORE® Tri-Lumen Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor W L Gore &…

Intended purpose

The GORE® Tri-Lumen Catheter is intended to be used in endovascular procedures requiring multiple guidewires and throughand-through access for the implantation of branched stent grafts.

Functional description

The device is a 140 cm long multi-lumen catheter comprised of a central lumen and two auxiliary lumens fitted with auxiliary lumen extensions at the trailing end to facilitate loading of the 0.018"or 0.014" guidewires. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires. The two auxiliary lumens can accommodate one 0.018" or 0.014" guidewire each. The device is 7.5 Fr (2.5 mm) in outer diameter and is compatible with a 12 Fr sheath or larger.

TGA Public Summary