FDA Product Code LJS: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Under FDA product code LJS, long-term implanted intravascular therapeutic catheters are cleared for extended vascular access over weeks to months.
These tunneled or implanted central venous catheters provide durable, reliable access to the central venous circulation for long-term chemotherapy, parenteral nutrition, hemodialysis, and repeated blood sampling without repeated peripheral venipuncture.
LJS devices are Class II medical devices, regulated under 21 CFR 880.5970 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Access Vascular, Inc., Piccolo Medical, Inc. and Bard Access Systems, Inc..
FDA 510(k) Cleared Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days Devices (Product Code LJS)
About Product Code LJS - Regulatory Context
510(k) Submission Activity
302 total 510(k) submissions under product code LJS since 1983, with 302 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for LJS submissions have been consistent, averaging 148 days recently vs 130 days historically.
LJS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →