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 Cordis Corp., Integra Lifesciences Production Corporation and Aesculap, Inc..

258
Total
258
Cleared
125d
Avg days
1976
Since
258 devices
25–48 of 258
Cleared Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289
Irras USA, Ltd.
Neurology · 84d
Cleared Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684
Integra LifeSciences Corporation
Neurology · 109d
Cleared Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174
Aesculap, Inc.
Neurology · 154d
Cleared Nov 20, 2018
CodMan Certas Plus Programmable Valve
K182265
Integra Lifesciences Corp.
Neurology · 91d
Cleared Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
K181902
Integra Lifesciences Corp.
Neurology · 101d
Cleared Oct 01, 2018
StrataMR guider tool
K181622
Medtronic Neurosurgery
Neurology · 103d
Cleared Jul 13, 2018
IRRAflow CNS System
K171880
Irras, Inc.
Neurology · 385d
Cleared Jun 14, 2018
Smart External Drain (SED) System
K181301
Aqueduct Critical Care, Inc.
Neurology · 28d
Cleared Mar 24, 2018
EKOS ultrasound EVD Device, EVD Control Unit
K172035
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
K172537
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K161853
Aesculap, Inc.
Neurology · 236d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265
Cordis Corp.
Neurology · 402d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159
Cordis Corp.
Neurology · 288d
Cleared Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832
Cordis Corp.
Neurology · 90d
Cleared Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595
Cordis Corp.
Neurology · 395d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429
Cordis Corp.
Neurology · 426d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810
Cordis Corp.
Neurology · 470d
Cleared Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600
Cordis Corp.
Neurology · 90d
Cleared Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K921936
Cordis Corp.
Neurology · 189d
Cleared Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995
Cordis Corp.
Neurology · 123d
Cleared Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842
Cordis Corp.
Neurology · 175d
Cleared Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636
Cordis Corp.
Neurology · 119d
Cleared Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433
Cordis Corp.
Neurology · 167d