Device Dossier

DECANAV™ Mapping Catheter - Electrophysiology cardiac catheter; single-use

Device Dossier for DECANAV™ Mapping Catheter - Electrophysiology cardiac catheter; single-use (Electrophysiology cardiac catheter, single-use, Class III,…

Intended purpose

The Decanav catheter is indicated for electrophysiological mapping of cardiac structure i.e., recording and stimulation, including in the Coronary Sinus. In addition the Decanav catheter is used with compatible CARTO 3 EP Navigation systems to provide catheter tip location information.

Functional description

Used with a cardiac mapping system to reference multiple catheters tip locations in the heart. Has a high torque shaft with a deflectable tip section containing an array of electrodes that can be used for stimulation and recording of cardiac electrical signals. Has a single proximal electrode that can be used for unipolar recording signals. The tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston.

TGA Public Summary