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 Pudenz-Schulte Medical Research Corp..

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
49–72 of 259
Cleared Oct 17, 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156
Medos International SARL
Neurology · 82d
Cleared Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381
Integra LifeSciences Corporation
Neurology · 416d
Cleared May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751
Codman & Shurtleff, Inc.
Neurology · 52d
Cleared Feb 18, 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
K102961
Codman & Shurtleff, Inc.
Neurology · 136d
Cleared Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
K102589
Codman & Shurtleff, Inc.
Neurology · 127d
Cleared Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003
Aesculap, Inc.
Neurology · 28d
Cleared Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
K093968
Integra LifeSciences Corporation
Neurology · 30d
Cleared Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
K091346
Codman & Shurtleff, Inc.
Neurology · 26d
Cleared Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K090348
Codman & Shurtleff, Inc.
Neurology · 21d
Cleared Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K072929
Integra LifeSciences Corporation
Neurology · 52d
Cleared Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009
Aesculap, Inc.
Neurology · 184d
Cleared Oct 16, 2006
CODMAN VPV SYSTEM, MODEL 82-3192
K061876
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
K061568
Codman & Shurtleff, Inc.
Neurology · 115d
Cleared Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K062599
Integra LifeSciences Corporation
Neurology · 26d
Cleared Jan 19, 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K053107
Codman & Shurtleff, Inc.
Neurology · 76d
Cleared Jan 19, 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K053350
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
K050739
Codman & Shurtleff, Inc.
Neurology · 119d
Cleared Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825
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
K041296
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303
Aesculap, Inc.
Neurology · 41d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698
Aesculap, Inc.
Neurology · 14d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030
Aesculap, Inc.
Neurology · 330d