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..
FDA 510(k) Cleared Port & Catheter, Implanted, Subcutaneous, Intravascular Devices (Product Code LJT)
About Product Code LJT - Regulatory Context
510(k) Submission Activity
287 total 510(k) submissions under product code LJT since 1983, with 287 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LJT have taken an average of 57 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.
LJT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →