Device Dossier

ThermoCool SF Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter

Device Dossier for ThermoCool SF Uni-Directional Catheter - Cardiac radio-frequency ablation system catheter (Cardiac radio-frequency ablation system…

Intended purpose

The Biosense Webster ThermoCool SF Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible radiofrequency generator, for cardiac ablation.

Functional description

This is a steerable, multi-electrode luminal catheter with a deflectable tip with an array of ring electrodes for recording and stimulation purposes. It incorporates a temperature sensor in th etip dome electrode. It interfaces with standard recording equipment and a compatible RF generator via accessory extension cables.

TGA Public Summary