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, Innovative Health, LLC and Biosense Webster, Inc..
FDA 510(k) Cleared Catheter, Electrode Recording, Or Probe, Electrode Recording Devices (Product Code DRF)
About Product Code DRF - Regulatory Context
510(k) Submission Activity
185 total 510(k) submissions under product code DRF since 1977, with 185 receiving FDA clearance (average review time: 169 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
FDA review times for DRF submissions have been consistent, averaging 191 days recently vs 168 days historically.
DRF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →