Device Dossier

Response Electrophysiology Catheter - Electrophysiology cardiac catheter, single-use

Device Dossier for Response Electrophysiology Catheter - Electrophysiology cardiac catheter, single-use (Electrophysiology cardiac catheter, single-use,…

Intended purpose

Electrophysiology diagnostic catheters are intended to be used for EP mapping, stimulation, and recording of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Functional description

The Response Electrophysiology (EP) Catheters are designed to facilitate EP mapping of the heart chambers and transmit pacing stimuli to the catheter electrodes to induce cardiac stimulation. The catheters have electrodes designed to detect cardiac signals that are transmitted to an electrocardiogram recorder for diagnosis or delivery the electrical signal for an external pacemaker to the heart for electrical pacing purposes.

TGA Public Summary