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.

260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
193–216 of 260
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 10, 1990
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
K895524
Theramed, Inc.
Neurology · 210d
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 Dec 22, 1988
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
K884036
Pmt Corp.
Neurology · 87d
Cleared Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616
Progress Mankind Technology
Neurology · 150d
Cleared Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114
Pmt Corp.
Neurology · 30d
Cleared Jul 14, 1988
H-H FLUSHING RESERVOIR
K875287
Holter-Hausner Intl.
Neurology · 198d
Cleared May 31, 1988
TRI-FLOW CATHETER
K875205
Neurodynamics, Inc.
Neurology · 165d
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 Jun 12, 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K871685
American V. Mueller
Neurology · 44d
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 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K864676
American V. Mueller
Neurology · 27d