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 27, 2015
Codman Certas Plus Programmable Valve
Medos International SARL
Neurology
85d
Cleared
Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
Sophysa SA
Neurology
325d
Cleared
Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
Aesculap, Inc.
Neurology
294d
Cleared
Feb 19, 2015
Codman Certas Plus Programmable Valve
Medos International SARL
Neurology
113d
Cleared
Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
Integra LifeSciences Corporation
Neurology
291d
Cleared
Dec 13, 2013
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
Moller Medical GmbH
Neurology
597d
Cleared
Mar 07, 2013
SHUNTCHECK
Neurodx Development, LLC
Neurology
108d
Cleared
Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
Medtronic Neurosurgery
Neurology
90d
Cleared
Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Codman & Shurtleff, Inc.
Neurology
17d
Cleared
May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
Aesculap, Inc.
Neurology
90d
Cleared
Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
Medos International SARL
Neurology
78d
Cleared
Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
Medtronic Neurosurgery
Neurology
263d
Cleared
Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
Aesculap, Inc.
Neurology
275d
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
Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
Integra Lifesciences Corp.
Neurology
106d
Cleared
Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
Medtronic Neurosurgery
Neurology
121d
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