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 Cordis Corp., Integra Lifesciences Production Corporation and Aesculap, Inc..
258
Total
258
Cleared
125d
Avg days
1976
Since
258 devices
Cleared
Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Irras USA, Ltd.
Neurology
84d
Cleared
Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Integra LifeSciences Corporation
Neurology
109d
Cleared
Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
Aesculap, Inc.
Neurology
154d
Cleared
Nov 20, 2018
CodMan Certas Plus Programmable Valve
Integra Lifesciences Corp.
Neurology
91d
Cleared
Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
Integra Lifesciences Corp.
Neurology
101d
Cleared
Oct 01, 2018
StrataMR guider tool
Medtronic Neurosurgery
Neurology
103d
Cleared
Jul 13, 2018
IRRAflow CNS System
Irras, Inc.
Neurology
385d
Cleared
Jun 14, 2018
Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
Neurology
28d
Cleared
Mar 24, 2018
EKOS ultrasound EVD Device, EVD Control Unit
Btg International, Inc.
Neurology
262d
Cleared
Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
Codman & Shurtleff, Inc.
Neurology
55d
Cleared
Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Codman & Shurtleff, Inc.
Neurology
90d
Cleared
Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
Aesculap, Inc.
Neurology
236d
Cleared
Dec 20, 1996
CORDIS SHARP-ENDED STYLET
Cordis Corp.
Neurology
402d
Cleared
Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
Cordis Corp.
Neurology
288d
Cleared
Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
Cordis Corp.
Neurology
90d
Cleared
Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
Cordis Corp.
Neurology
395d
Cleared
Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
Cordis Corp.
Neurology
426d
Cleared
Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
Cordis Corp.
Neurology
470d
Cleared
Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
Cordis Corp.
Neurology
90d
Cleared
Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
Cordis Corp.
Neurology
189d
Cleared
Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
Cordis Corp.
Neurology
123d
Cleared
Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
Cordis Corp.
Neurology
175d
Cleared
Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
Cordis Corp.
Neurology
119d
Cleared
Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
Cordis Corp.
Neurology
167d