FDA Product Code LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular
Implanted venous access ports provide long-term reliable vascular access. FDA product code LJT covers subcutaneously implanted intravascular port and catheter systems.
These totally implanted systems consist of a subcutaneous reservoir with a silicone septum connected to a central venous catheter, providing repeated vascular access for chemotherapy, blood sampling, and parenteral nutrition without repeated venipuncture.
LJT devices are Class II medical devices, regulated under 21 CFR 880.5965 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Bard Access Systems, Inc. and Bard Peripheral Vascular, Inc..
List of Port & Catheter, Implanted, Subcutaneous, Intravascular devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Port & Catheter, Implanted, Subcutaneous, Intravascular devices (product code LJT). 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 →