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
Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
Codman & Shurtleff, Inc.
Neurology
30d
Cleared
Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Radionics, Inc.
Neurology
399d
Cleared
Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
Johnson & Johnson Professionals, Inc.
Neurology
284d
Cleared
Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
Radionics, Inc.
Neurology
70d
Cleared
Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
Radionics, Inc.
Neurology
54d
Cleared
Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
Radionics, Inc.
Neurology
405d
Cleared
Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
Johnson & Johnson Professionals, Inc.
Neurology
137d
Cleared
Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
Johnson & Johnson Professionals, Inc.
Neurology
194d
Cleared
Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
Johnson & Johnson Professionals, Inc.
Neurology
87d
Cleared
Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
Radionics, Inc.
Neurology
87d
Cleared
Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
Johnson & Johnson Professionals, Inc.
Neurology
198d
Cleared
Jun 04, 1997
RADIONICS BURR HOLE VALVE
Radionics, Inc.
Neurology
110d
Cleared
Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
Radionics, Inc.
Neurology
88d
Cleared
Dec 20, 1996
CORDIS SHARP-ENDED STYLET
Cordis Corp.
Neurology
402d
Cleared
Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
Cordis Corp.
Neurology
288d
Cleared
Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
Radionics, Inc.
Neurology
83d
Cleared
Aug 29, 1996
VENTRICULAR CATHETER SET
Cook, Inc.
Neurology
92d
Cleared
Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
Cordis Corp.
Neurology
90d
Cleared
Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
Radionics, Inc.
Neurology
134d
Cleared
Oct 24, 1995
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
Johnson & Johnson Professionals, Inc.
Neurology
85d
Cleared
Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
Cordis Corp.
Neurology
395d
Cleared
Sep 18, 1995
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
Pudenz-Schulte Medical Research Corp.
Neurology
181d
Cleared
Jul 28, 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
Johnson & Johnson Professionals, Inc.
Neurology
332d
Cleared
Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
Cordis Corp.
Neurology
426d