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, Surgical Instrument Service and Savings, Inc. and Innovative Health.
FDA 510(k) Cleared Reprocessed Catheter Introducer Devices (Product Code PNE)
About Product Code PNE - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PNE since 2016, with 7 receiving FDA clearance (average review time: 243 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PNE have taken an average of 328 days to reach a decision - up from 209 days historically. Manufacturers should account for longer review timelines in current project planning.
PNE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →