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
169–192 of 259
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 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 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
Cleared Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907
Pudenz-Schulte Medical Research Corp.
Neurology · 125d
Cleared Aug 12, 1986
CAMINO CSF DRAINAGE SYSTEM MODEL 040
K861961
Camino Laboratories, Inc.
Neurology · 84d
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