JXG · Class II · 21 CFR 882.5550

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
121–144 of 259
Cleared Jun 16, 1998
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
K981046
Medtronic PS Medical
Neurology · 88d
Cleared Mar 18, 1998
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
K974726
Elekta Implants, SA
Neurology · 90d
Cleared Mar 10, 1998
GEMINI STANDARD AND MINI VALVES
K974708
Neurocare Group
Neurology · 83d
Cleared Feb 06, 1998
PRECISION FLOW OSV II
K971799
Elekta Implants, SA
Neurology · 267d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774
Johnson & Johnson Professionals, Inc.
Neurology · 87d
Cleared Dec 16, 1997
MAURICE WORLDWIDE SHUNT SYSTEM
K973525
Integra Neurocare, LLC
Neurology · 90d
Cleared Nov 03, 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K972994
Integra Neurocare, LLC
Neurology · 83d
Cleared Jul 31, 1997
ENDOSCOPIC VENTRICULAR CATHETER
K971617
Integra Neurocare, LLC
Neurology · 90d
Cleared Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511
Radionics, Inc.
Neurology · 87d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923
Johnson & Johnson Professionals, Inc.
Neurology · 198d
Cleared Jun 13, 1997
PERITONEAL/CARDIAC CATHETER
K970983
Integra Neurocare, LLC
Neurology · 87d
Cleared Jun 04, 1997
RADIONICS BURR HOLE VALVE
K970578
Radionics, Inc.
Neurology · 110d
Cleared May 19, 1997
LUMBAR DRAINAGE ACCESSORY KIT
K970658
Integra Neurocare, LLC
Neurology · 87d
Cleared Jan 31, 1997
SHUNT TAP WITH ICP MONITORING ACCESS PORT
K964371
Integra Neurocare, LLC
Neurology · 91d
Cleared Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386
Radionics, Inc.
Neurology · 88d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265
Cordis Corp.
Neurology · 402d
Cleared Dec 16, 1996
NOVUS STANDARD AND PEDIATRIC VALVES
K961859
Integra Neurocare, LLC
Neurology · 216d
Cleared Dec 12, 1996
SHUNT TAP
K963802
Integra Neurocare, LLC
Neurology · 80d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159
Cordis Corp.
Neurology · 288d
Cleared Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990
Radionics, Inc.
Neurology · 83d
Cleared Aug 29, 1996
VENTRICULAR CATHETER SET
K962097
Cook, Inc.
Neurology · 92d
Cleared Aug 27, 1996
PHOENIX CRX VALVE
K960435
Phoenix Biomedical Corp.
Neurology · 209d
Cleared Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832
Cordis Corp.
Neurology · 90d
Cleared Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
K954285
Radionics, Inc.
Neurology · 134d