FDA Product Code DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Electrophysiology studies require precise mapping of electrical activity within the heart. FDA product code DRF covers electrode recording catheters and electrode probes used in cardiac electrophysiology.

These catheters are equipped with multiple electrode contacts that simultaneously record intracardiac electrograms from different locations, enabling the identification and mapping of arrhythmia substrates before ablation therapy.

DRF 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., St Jude Medical and Ep Technologies, Inc..