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 Medtronic Neurosurgery.

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
193–216 of 259
Cleared Nov 27, 1985
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
K854049
American V. Mueller
Neurology · 55d
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
Cleared Dec 16, 1982
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K823509
Pudenz-Schulte Medical Research Corp.
Neurology · 20d
Cleared Mar 01, 1982
H-H RICKHAM TYPE RESERVOIR
K820312
Holter-Hausner Intl.
Neurology · 24d
Cleared Feb 24, 1982
H-H BURR HOLE CATHETER SUPPORT
K820311
Holter-Hausner Intl.
Neurology · 19d
Cleared Jan 22, 1981
CSG-FLOW CONTROL VALVE
K803257
Pudenz-Schulte Medical Research Corp.
Neurology · 30d
Cleared Jan 31, 1980
H-H FIFTH VENTRICLE
K800168
Holter-Hausner Intl.
Neurology · 6d
Cleared Jan 16, 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Jan 16, 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
K791075
Holter-Hausner Intl.
Neurology · 52d