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 Biosense Webster, Inc., Acutus Medical, Inc. and Medtronic.
List of Catheter, Intracardiac Mapping, High-density Array devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Intracardiac Mapping, High-density Array devices (product code MTD). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →