Device Dossier

FlexCath Contour Steerable Sheath - Catheter, intravascular, guiding

Device Dossier for FlexCath Contour Steerable Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Medtronic).…

Intended purpose

The intended purpose of FlexCath Contour 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 Contour Steerable 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