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
Oct 17, 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
Medos International SARL
Neurology
82d
Cleared
Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
Integra LifeSciences Corporation
Neurology
416d
Cleared
May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
Codman & Shurtleff, Inc.
Neurology
52d
Cleared
Feb 18, 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
Codman & Shurtleff, Inc.
Neurology
136d
Cleared
Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
Codman & Shurtleff, Inc.
Neurology
127d
Cleared
Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
Aesculap, Inc.
Neurology
28d
Cleared
Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
Integra LifeSciences Corporation
Neurology
30d
Cleared
Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
Codman & Shurtleff, Inc.
Neurology
26d
Cleared
Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
Codman & Shurtleff, Inc.
Neurology
21d
Cleared
Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
Integra LifeSciences Corporation
Neurology
52d
Cleared
Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
Aesculap, Inc.
Neurology
184d
Cleared
Oct 16, 2006
CODMAN VPV SYSTEM, MODEL 82-3192
Codman & Shurtleff, Inc.
Neurology
105d
Cleared
Sep 29, 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
Codman & Shurtleff, Inc.
Neurology
115d
Cleared
Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
Integra LifeSciences Corporation
Neurology
26d
Cleared
Jan 19, 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
Codman & Shurtleff, Inc.
Neurology
76d
Cleared
Jan 19, 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
Codman & Shurtleff, Inc.
Neurology
48d
Cleared
Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
Codman & Shurtleff, Inc.
Neurology
119d
Cleared
Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
Integra LifeSciences Corporation
Neurology
70d
Cleared
Jun 10, 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
Codman & Shurtleff, Inc.
Neurology
27d
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
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