Device Dossier

PathBuilder Transseptal Guiding Introducer - Catheter introducer, haemostasis valve

Device Dossier for PathBuilder Transseptal Guiding Introducer - Catheter introducer, haemostasis valve (Catheter introducer, haemostasis valve, Class…

Intended purpose

PathBuilder Transseptal Guiding Introducer is indicated for introducing various cardiovascular catheters into the heart via femoral vein, including the left side of the heart through the interatrial septum, and when used with cardiovascular catheters, for assisting catheters in reaching the target site.

Functional description

PathBuilder Transseptal Guiding Introducer is designed to introduce various cardiovascular catheters into each heart chamber for further electrophysiology operation. It is comprised of a sheath, a dilator and a guidewire. The sheath has a marker band on the tip to observe the position of catheter at any time, valves to provide hemostasis, and a three-way stopcock on its sideport that can be used for aspiration, fluid infusion, blood sampling and pressure monitoring.

TGA Public Summary