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.
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
Cleared
Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
Medtronic Neurosurgery
Neurology
33d
Cleared
Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
Aesculap, Inc.
Neurology
41d
Cleared
Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
Aesculap, Inc.
Neurology
14d
Cleared
Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
Integra Lifesciences Corp.
Neurology
29d
Cleared
Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
Codman & Shurtleff, Inc.
Neurology
70d
Cleared
Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
Codman & Shurtleff, Inc.
Neurology
27d
Cleared
Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
Aesculap, Inc.
Neurology
330d
Cleared
Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
Codman & Shurtleff, Inc.
Neurology
30d
Cleared
Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
Sophysa SA
Neurology
426d
Cleared
Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
Medtronic PS Medical
Neurology
502d
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 23, 1999
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
Nmt Neurosciences Implants S.A.
Neurology
206d
Cleared
Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
Radionics, Inc.
Neurology
54d
Cleared
May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
Integra Neurocare, LLC
Neurology
415d
Cleared
May 19, 1999
DIAMOND II VALVE
Phoenix Biomedical Corp.
Neurology
23d
Cleared
Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
Radionics, Inc.
Neurology
405d
Cleared
Apr 01, 1999
CRX WORLD SHUNT
Phoenix Biomedical Corp.
Neurology
64d
Cleared
Mar 15, 1999
THE BIOPLATE SHUNT CONNECTOR
Biomedics
Neurology
81d
Cleared
Feb 04, 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
Medtronic PS Medical
Neurology
90d
Cleared
Dec 08, 1998
CRX DIAMOND VALVE
Phoenix Biomedical Corp.
Neurology
404d
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