510(k) for Cardiac Pathways' high density array catheter:
This article was originally published in Clinica
Executive Summary
Cardiac Pathways has received clearance from the US FDA to market its Mercator atrial high-density array catheter. The device is designed to diagnose and map complex arrhythmias, which conventional mapping systems might not be able to detect. It is used in conjunction with the company's model 8100/8300 arrhythmia mapping system which captures and displays information about the conduction activity in the right atrium.