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., Cortex, Inc. and Acutus Medical, Inc..
FDA 510(k) Cleared Catheter, Intracardiac Mapping, High-density Array Devices (Product Code MTD)
About Product Code MTD - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code MTD since 1999, with 34 receiving FDA clearance (average review time: 143 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
FDA review times for MTD submissions have been consistent, averaging 138 days recently vs 144 days historically.
MTD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →