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 Sterilmed, Inc..
List of Catheter, Recording, Electrode, Reprocessed devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Recording, Electrode, Reprocessed devices (product code NLH). 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 →