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 Cordis Corp..

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
121–144 of 259
Cleared Jan 19, 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K874508
Holter-Hausner Intl.
Neurology · 78d
Cleared Sep 18, 1987
CSF-FLOW CONTROL VALVE, ULTRA SMALL
K873247
Pudenz-Schulte Medical Research Corp.
Neurology · 35d
Cleared May 22, 1987
CSF-CARDIAC/PERITONEAL CATHETER
K871752
Pudenz-Schulte Medical Research Corp.
Neurology · 14d
Cleared May 01, 1987
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
K870660
Holter-Hausner Intl.
Neurology · 71d
Cleared Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907
Pudenz-Schulte Medical Research Corp.
Neurology · 125d
Cleared Aug 12, 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K862303
Pudenz-Schulte Medical Research Corp.
Neurology · 56d
Cleared Aug 01, 1986
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513
Cordis Corp.
Neurology · 31d
Cleared Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377
Cordis Corp.
Neurology · 66d
Cleared Jan 10, 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058
Cordis Corp.
Neurology · 23d
Cleared Nov 27, 1985
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474
Cordis Corp.
Neurology · 20d
Cleared Sep 18, 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K853371
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 16, 1985
ACCU-FLO PRESSURE VALVE
K853215
Codman & Shurtleff, Inc.
Neurology · 46d
Cleared Sep 11, 1985
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
K853366
Holter-Hausner Intl.
Neurology · 30d
Cleared Sep 11, 1985
H-H FIXATION & JOINING CONNECTORS
K853369
Holter-Hausner Intl.
Neurology · 30d
Cleared Sep 05, 1985
H-H RICKHAM TYPE RESERVOIR
K853364
Holter-Hausner Intl.
Neurology · 24d
Cleared Sep 05, 1985
H-H FIFTH VENTRICLE
K853365
Holter-Hausner Intl.
Neurology · 24d
Cleared Sep 03, 1985
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
K853362
Holter-Hausner Intl.
Neurology · 22d
Cleared Sep 03, 1985
H-H CRUCIFORM-SLIT VALVE
K853363
Holter-Hausner Intl.
Neurology · 22d
Cleared Aug 28, 1985
H-H VENTRICULAR CATHETERS & RESERVOIRS
K853361
Holter-Hausner Intl.
Neurology · 16d
Cleared Sep 12, 1984
RADIONICS MINI & STANDARD SHUNT VALVE
K843132
Radionics, Inc.
Neurology · 34d
Cleared Aug 12, 1983
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
K831396
Pudenz-Schulte Medical Research Corp.
Neurology · 105d
Cleared Jun 24, 1983
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
K831678
Pudenz-Schulte Medical Research Corp.
Neurology · 32d
Cleared Apr 08, 1983
H-H IN-LINE VALVED CATHETER 2 TYPES
K830894
Holter-Hausner Intl.
Neurology · 18d
Cleared Mar 09, 1983
P-S CSF-VENTRICULAR CATHETER, FLANGED
K823503
Pudenz-Schulte Medical Research Corp.
Neurology · 105d