FDA Product Code NLH: Catheter, Recording, Electrode, Reprocessed
Under FDA product code NLH, reprocessed electrode recording catheters are cleared for use in cardiac electrophysiology after a validated reprocessing cycle.
Single-use electrophysiology catheters are expensive, and reprocessing provides a cost-effective alternative that must meet rigorous cleaning, sterilization, and functional validation standards. Reprocessed NLH catheters must demonstrate equivalent safety and performance to the original device.
NLH devices are Class II medical devices, regulated under 21 CFR 870.1220 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Surgical Instrument Service and Savings, Inc., Innovative Health, LLC and Innovative Health.
FDA 510(k) Cleared Catheter, Recording, Electrode, Reprocessed Devices (Product Code NLH)
About Product Code NLH - Regulatory Context
510(k) Submission Activity
70 total 510(k) submissions under product code NLH since 2002, with 70 receiving FDA clearance (average review time: 156 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for NLH submissions have been consistent, averaging 143 days recently vs 158 days historically.
NLH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →