FDA Product Code PNE: Reprocessed Catheter Introducer
FDA product code PNE covers reprocessed catheter introducers cleared for cardiovascular use after validated reprocessing.
Vascular access sheaths and introducers are standard single-use devices in interventional cardiology. Reprocessing provides a cost-effective alternative that must demonstrate equivalent sterility, structural integrity, and hemostatic valve function to the original device.
PNE devices are Class II medical devices, regulated under 21 CFR 870.1340 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Innovative Health, LLC and Surgical Instrument Service and Savings, Inc..
List of Reprocessed Catheter Introducer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Reprocessed Catheter Introducer devices (product code PNE). 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 →