FDA Product Code PTI: Non-coring (huber) Needle
FDA product code PTI covers non-coring Huber needles used to access implanted subcutaneous ports.
These specialized needles have a deflected tip that pierces the silicone port membrane without coring out material, allowing repeated access to implanted venous access ports for chemotherapy, parenteral nutrition, and blood sampling without damaging the port septum.
PTI devices are Class II medical devices, regulated under 21 CFR 880.5570 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd., Jiangsu Caina Medical Co.,Ltd and Bard Access Systems, Inc..
List of Non-coring (huber) Needle devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Non-coring (huber) Needle devices (product code PTI). 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 General Hospital FDA review panel. Browse all General Hospital devices →