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 Innovative Health, LLC, Sterilmed, Inc. and Vanguard Medical Concepts, Inc..