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 Bard Access Systems, Inc. and C.R. Bard, Inc..
List of Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days devices (product code LJS). 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 →