FDA Product Code JXG: Shunt, Central Nervous System And Components
Hydrocephalus is managed with shunt systems that divert excess cerebrospinal fluid. FDA product code JXG covers central nervous system shunts and their components.
These implanted systems typically consist of a ventricular catheter, a valve mechanism, and a distal catheter that diverts excess cerebrospinal fluid from the ventricles to the peritoneal cavity, pleura, or atrium. Programmable valves allow non-invasive adjustment of drainage pressure.
JXG devices are Class II medical devices, regulated under 21 CFR 882.5550 and reviewed by the FDA Neurology panel.
Leading manufacturers include Cordis Corp., Integra Lifesciences Production Corporation and Aesculap, Inc..
258
Total
258
Cleared
125d
Avg days
1976
Since
258 devices
Cleared
Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
Baxter Healthcare Corp
Neurology
263d
Cleared
Jul 24, 1991
OPTYX
Baxter Healthcare Corp
Neurology
271d
Cleared
Apr 24, 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
Cordis Corp.
Neurology
55d
Cleared
Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
Cordis Corp.
Neurology
129d
Cleared
Aug 07, 1989
THE PUDENZ IN LINE VALVE
Baxter Healthcare Corp
Neurology
60d
Cleared
Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
Baxter Healthcare Corp
Neurology
100d
Cleared
Aug 01, 1986
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
Cordis Corp.
Neurology
31d
Cleared
Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
Cordis Corp.
Neurology
66d
Cleared
Jan 10, 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
Cordis Corp.
Neurology
23d
Cleared
Nov 27, 1985
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
Cordis Corp.
Neurology
20d