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 Cordis Corp..
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
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
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 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
Pudenz-Schulte Medical Research Corp.
Neurology
125d
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
Cleared
Nov 27, 1985
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
Cordis Corp.
Neurology
20d
Cleared
Sep 18, 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
Holter-Hausner Intl.
Neurology
37d
Cleared
Sep 16, 1985
ACCU-FLO PRESSURE VALVE
Codman & Shurtleff, Inc.
Neurology
46d
Cleared
Sep 11, 1985
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
Holter-Hausner Intl.
Neurology
30d
Cleared
Sep 11, 1985
H-H FIXATION & JOINING CONNECTORS
Holter-Hausner Intl.
Neurology
30d
Cleared
Sep 05, 1985
H-H RICKHAM TYPE RESERVOIR
Holter-Hausner Intl.
Neurology
24d
Cleared
Sep 05, 1985
H-H FIFTH VENTRICLE
Holter-Hausner Intl.
Neurology
24d
Cleared
Sep 03, 1985
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
Holter-Hausner Intl.
Neurology
22d
Cleared
Sep 03, 1985
H-H CRUCIFORM-SLIT VALVE
Holter-Hausner Intl.
Neurology
22d
Cleared
Aug 28, 1985
H-H VENTRICULAR CATHETERS & RESERVOIRS
Holter-Hausner Intl.
Neurology
16d
Cleared
Sep 12, 1984
RADIONICS MINI & STANDARD SHUNT VALVE
Radionics, Inc.
Neurology
34d
Cleared
Aug 12, 1983
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
Pudenz-Schulte Medical Research Corp.
Neurology
105d
Cleared
Jun 24, 1983
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
Pudenz-Schulte Medical Research Corp.
Neurology
32d
Cleared
Apr 08, 1983
H-H IN-LINE VALVED CATHETER 2 TYPES
Holter-Hausner Intl.
Neurology
18d
Cleared
Mar 09, 1983
P-S CSF-VENTRICULAR CATHETER, FLANGED
Pudenz-Schulte Medical Research Corp.
Neurology
105d