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 Boston Scientific Corporation, Biotronik, Inc. and Innovative Health, LLC.
List of Catheter, Electrode Recording, Or Probe, Electrode Recording devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Electrode Recording, Or Probe, Electrode Recording devices (product code DRF). 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 →