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 Pudenz-Schulte Medical Research Corp..

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
97–120 of 259
Cleared Apr 28, 1994
PS MEDICAL DELTA BURR HOLE VALVE
K934545
Pudenz-Schulte Medical Research Corp.
Neurology · 218d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810
Cordis Corp.
Neurology · 470d
Cleared Mar 30, 1993
PS MEDICAL CSF-ACCESS DEVICE
K913412
Pudenz-Schulte Medical Research Corp.
Neurology · 608d
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
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860
Baxter Healthcare Corp
Neurology · 263d
Cleared Aug 16, 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938
Codman & Shurtleff, Inc.
Neurology · 163d
Cleared Jul 24, 1991
OPTYX
K904883
Baxter Healthcare Corp
Neurology · 271d
Cleared Jun 28, 1991
PS MEDICAL BUTTON VALVE
K911410
Pudenz-Schulte Medical Research Corp.
Neurology · 88d
Cleared Apr 24, 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853
Cordis Corp.
Neurology · 55d
Cleared Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844
Cordis Corp.
Neurology · 129d
Cleared Oct 09, 1990
ACCU-FLO* UNITIZED SHUNT
K904120
Codman & Shurtleff, Inc.
Neurology · 33d
Cleared Aug 08, 1990
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
K902783
Pudenz-Schulte Medical Research Corp.
Neurology · 43d
Cleared Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257
Codman & Shurtleff, Inc.
Neurology · 59d
Cleared Apr 03, 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K900676
Pudenz-Schulte Medical Research Corp.
Neurology · 50d
Cleared Dec 21, 1989
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167
Pudenz-Schulte Medical Research Corp.
Neurology · 57d
Cleared Aug 21, 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215
Codman & Shurtleff, Inc.
Neurology · 140d
Cleared Aug 07, 1989
THE PUDENZ IN LINE VALVE
K894072
Baxter Healthcare Corp
Neurology · 60d
Cleared Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456
Baxter Healthcare Corp
Neurology · 100d
Cleared Jul 14, 1988
H-H FLUSHING RESERVOIR
K875287
Holter-Hausner Intl.
Neurology · 198d