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 Codman & Shurtleff, Inc., Holter-Hausner Intl. and Pudenz-Schulte Medical Research Corp..
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
Cleared
Apr 28, 1994
PS MEDICAL DELTA BURR HOLE VALVE
Pudenz-Schulte Medical Research Corp.
Neurology
218d
Cleared
Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
Cordis Corp.
Neurology
470d
Cleared
Mar 30, 1993
PS MEDICAL CSF-ACCESS DEVICE
Pudenz-Schulte Medical Research Corp.
Neurology
608d
Cleared
Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
Cordis Corp.
Neurology
90d
Cleared
Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
Cordis Corp.
Neurology
189d
Cleared
Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
Cordis Corp.
Neurology
123d
Cleared
Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
Cordis Corp.
Neurology
175d
Cleared
Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
Cordis Corp.
Neurology
119d
Cleared
Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
Cordis Corp.
Neurology
167d
Cleared
Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
Baxter Healthcare Corp
Neurology
263d
Cleared
Aug 16, 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
Codman & Shurtleff, Inc.
Neurology
163d
Cleared
Jul 24, 1991
OPTYX
Baxter Healthcare Corp
Neurology
271d
Cleared
Jun 28, 1991
PS MEDICAL BUTTON VALVE
Pudenz-Schulte Medical Research Corp.
Neurology
88d
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
Oct 09, 1990
ACCU-FLO* UNITIZED SHUNT
Codman & Shurtleff, Inc.
Neurology
33d
Cleared
Aug 08, 1990
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
Pudenz-Schulte Medical Research Corp.
Neurology
43d
Cleared
Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
Codman & Shurtleff, Inc.
Neurology
59d
Cleared
Apr 03, 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
Pudenz-Schulte Medical Research Corp.
Neurology
50d
Cleared
Dec 21, 1989
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
Pudenz-Schulte Medical Research Corp.
Neurology
57d
Cleared
Aug 21, 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
Codman & Shurtleff, Inc.
Neurology
140d
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
Jul 14, 1988
H-H FLUSHING RESERVOIR
Holter-Hausner Intl.
Neurology
198d