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 Medtronic Neurosurgery.
260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
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 10, 1990
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
Theramed, Inc.
Neurology
210d
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
Dec 22, 1988
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
Pmt Corp.
Neurology
87d
Cleared
Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
Progress Mankind Technology
Neurology
150d
Cleared
Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
Pmt Corp.
Neurology
30d
Cleared
Jul 14, 1988
H-H FLUSHING RESERVOIR
Holter-Hausner Intl.
Neurology
198d
Cleared
May 31, 1988
TRI-FLOW CATHETER
Neurodynamics, Inc.
Neurology
165d
Cleared
Jan 19, 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
Holter-Hausner Intl.
Neurology
78d
Cleared
Sep 18, 1987
CSF-FLOW CONTROL VALVE, ULTRA SMALL
Pudenz-Schulte Medical Research Corp.
Neurology
35d
Cleared
Jun 12, 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
American V. Mueller
Neurology
44d
Cleared
May 22, 1987
CSF-CARDIAC/PERITONEAL CATHETER
Pudenz-Schulte Medical Research Corp.
Neurology
14d
Cleared
May 01, 1987
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
Holter-Hausner Intl.
Neurology
71d
Cleared
Dec 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
American V. Mueller
Neurology
27d