Device Dossier

FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve

Device Dossier for FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve (Catheter introducer, haemostasis valve, Class III, sponsor…

Intended purpose

The intended purpose of FlexCath Advance steerable sheath is to provide percutaneous introduction into the vasculature and chambers of the heart, and to facilitate positioning of compatible devices.

Functional description

The FlexCath Advance steerable sheath (the sheath) is a percutaneous catheter introducer fitted with a hemostasis valve to allow for introduction, withdrawal, and swapping of catheters and wires while minimizing blood loss. A sideport with three-way stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, air or blood aspiration, blood sampling, and pressure monitoring.

TGA Public Summary