Device Dossier

PathBuilder Steerable Introducer - Catheter introducer, haemostasis valve

Device Dossier for PathBuilder Steerable Introducer - Catheter introducer, haemostasis valve (Catheter introducer, haemostasis valve, Class III, sponsor…

Intended purpose

PathBuilder Steerable Introducer is indicated for introducing various cardiovascular catheters from femoral vein into left atrium through the interatrial septum, and when used with cardiovascular catheters, for assisting catheters in reaching the target site.

Functional description

PathBuilder Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It can be inserted into various cardiovascular catheters, including guiding cardiovascular catheters into the left side of the heart. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring.

TGA Public Summary