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 Piccolo Medical, Inc., Access Vascular, Inc. and Bard Access Systems, Inc..