Device Dossier

Safire BLU Duo Catheter - Catheter, cardiac, electrophysiological mapping

Device Dossier for Safire BLU Duo Catheter - Catheter, cardiac, electrophysiological mapping (Catheter, cardiac, electrophysiological mapping, Class III,…

Intended purpose

The Safire BLU Duo Catheter is intended for creating focal endocardial lesions during cardiac ablation procedures to treat arrhythmias and for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli.

Functional description

The Safire BLU Duo Catheter is a flexible, insulated, which has a lumen connected to open conduits at the tip electrode for saline irrigation during ablation with a compatible RF generator. The tip shape may be manipulated in two directions by the thumb and forefinger control mechanism located in the handle at the proximal end of the catheter. It is irrigated with 12 holes.

TGA Public Summary