FDA Product Code MTD: Catheter, Intracardiac Mapping, High-density Array

High-density mapping has transformed the treatment of complex cardiac arrhythmias. FDA product code MTD covers high-density array intracardiac mapping catheters.

These catheters carry multiple closely-spaced electrode arrays that simultaneously record electrical signals from a large area of cardiac tissue, generating detailed activation maps that reveal the mechanisms and anatomical substrates of arrhythmias before ablation therapy.

MTD devices are Class II medical devices, regulated under 21 CFR 870.1220 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Boston Scientific Corp, Biosense Webster, Inc. and Acutus Medical, Inc..