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 Cordis Corp..
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
Cleared
Jun 16, 1998
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
Medtronic PS Medical
Neurology
88d
Cleared
Mar 18, 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
Elekta Implants, SA
Neurology
90d
Cleared
Mar 10, 1998
GEMINI STANDARD AND MINI VALVES
Neurocare Group
Neurology
83d
Cleared
Feb 06, 1998
PRECISION FLOW OSV II
Elekta Implants, SA
Neurology
267d
Cleared
Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
Johnson & Johnson Professionals, Inc.
Neurology
87d
Cleared
Dec 16, 1997
MAURICE WORLDWIDE SHUNT SYSTEM
Integra Neurocare, LLC
Neurology
90d
Cleared
Nov 03, 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
Integra Neurocare, LLC
Neurology
83d
Cleared
Jul 31, 1997
ENDOSCOPIC VENTRICULAR CATHETER
Integra Neurocare, LLC
Neurology
90d
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 13, 1997
PERITONEAL/CARDIAC CATHETER
Integra Neurocare, LLC
Neurology
87d
Cleared
Jun 04, 1997
RADIONICS BURR HOLE VALVE
Radionics, Inc.
Neurology
110d
Cleared
May 19, 1997
LUMBAR DRAINAGE ACCESSORY KIT
Integra Neurocare, LLC
Neurology
87d
Cleared
Jan 31, 1997
SHUNT TAP WITH ICP MONITORING ACCESS PORT
Integra Neurocare, LLC
Neurology
91d
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
Dec 16, 1996
NOVUS STANDARD AND PEDIATRIC VALVES
Integra Neurocare, LLC
Neurology
216d
Cleared
Dec 12, 1996
SHUNT TAP
Integra Neurocare, LLC
Neurology
80d
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
Aug 27, 1996
PHOENIX CRX VALVE
Phoenix Biomedical Corp.
Neurology
209d
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