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
Cleared
Oct 09, 1990
ACCU-FLO* UNITIZED SHUNT
Codman & Shurtleff, Inc.
Neurology
33d
Cleared
Aug 08, 1990
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
Pudenz-Schulte Medical Research Corp.
Neurology
43d
Cleared
Jul 19, 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
Codman & Shurtleff, Inc.
Neurology
59d
Cleared
Apr 03, 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
Pudenz-Schulte Medical Research Corp.
Neurology
50d
Cleared
Dec 21, 1989
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
Pudenz-Schulte Medical Research Corp.
Neurology
57d
Cleared
Aug 21, 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
Codman & Shurtleff, Inc.
Neurology
140d
Cleared
Aug 07, 1989
THE PUDENZ IN LINE VALVE
Baxter Healthcare Corp
Neurology
60d
Cleared
Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
Baxter Healthcare Corp
Neurology
100d
Cleared
Dec 22, 1988
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
Pmt Corp.
Neurology
87d
Cleared
Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
Progress Mankind Technology
Neurology
150d
Cleared
Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
Pmt Corp.
Neurology
30d
Cleared
Jul 14, 1988
H-H FLUSHING RESERVOIR
Holter-Hausner Intl.
Neurology
198d
Cleared
Jan 19, 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
Holter-Hausner Intl.
Neurology
78d
Cleared
Sep 18, 1987
CSF-FLOW CONTROL VALVE, ULTRA SMALL
Pudenz-Schulte Medical Research Corp.
Neurology
35d
Cleared
Jun 12, 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
American V. Mueller
Neurology
44d
Cleared
May 22, 1987
CSF-CARDIAC/PERITONEAL CATHETER
Pudenz-Schulte Medical Research Corp.
Neurology
14d
Cleared
May 01, 1987
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
Holter-Hausner Intl.
Neurology
71d
Cleared
Dec 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
American V. Mueller
Neurology
27d
Cleared
Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
Pudenz-Schulte Medical Research Corp.
Neurology
125d
Cleared
Aug 12, 1986
CAMINO CSF DRAINAGE SYSTEM MODEL 040
Camino Laboratories, Inc.
Neurology
84d
Cleared
Aug 12, 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
Pudenz-Schulte Medical Research Corp.
Neurology
56d
Cleared
Aug 01, 1986
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
Cordis Corp.
Neurology
31d
Cleared
Jun 19, 1986
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
Cordis Corp.
Neurology
66d
Cleared
Jan 10, 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
Cordis Corp.
Neurology
23d