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..

260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
73–96 of 260
Cleared Aug 11, 2009
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
K090342
Sophysa SA
Neurology · 182d
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 Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K083076
Medtronic Neurosurgery
Neurology · 35d
Cleared Nov 06, 2008
OSV II
K081773
Integra Neurosciences Implants S.A.
Neurology · 136d
Cleared Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127
Medtronic Neurosurgery
Neurology · 29d
Cleared Aug 12, 2008
NEUROCATH AG
K081942
Vygon Neuro
Neurology · 35d
Cleared May 16, 2008
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
K080168
Neuro Diagnostic Devices
Neurology · 114d
Cleared Jan 30, 2008
SMALL LUMEN PERITONEAL CATHETER
K073139
Medtronic Neurosurgery
Neurology · 84d
Cleared Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K072929
Integra LifeSciences Corporation
Neurology · 52d
Cleared Aug 16, 2007
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
K063836
Medtronic Neurosurgery
Neurology · 233d
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 Sep 15, 2006
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
K060681
Medtronic Neurosurgery
Neurology · 184d
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 Dec 16, 2005
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
K052386
Medtronic Neurosurgery
Neurology · 107d
Cleared Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
K050739
Codman & Shurtleff, Inc.
Neurology · 119d
Cleared Jan 28, 2005
MEDTRONIC STRATAVARIUS
K041992
Medtronic Neurosurgery
Neurology · 189d
Cleared Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825
Integra LifeSciences Corporation
Neurology · 70d
Cleared Dec 14, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
K042481
Sophysa SA
Neurology · 92d
Cleared Nov 17, 2004
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
K042359
Medical Designs, LLC
Neurology · 78d