Ablation catheter receives 510(K) clearance:
This article was originally published in Clinica
Executive Summary
Biosense Webster has received 510(K) clearance for its Celsius II Bi-Directional Ablation Catheter for cardiac mapping and ablation. The design provides directional control with a handle and tip that respond simultaneously, simplicity and speed. The device gives electrophysiologists access to a diagnostic and ablation tool enable control in an anatomical situation or constraint.