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
Nov 27, 1985
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
American V. Mueller
Neurology
55d
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
Cleared
Dec 16, 1982
P-S MED. LUMBO PERITONEAL & VENTRICULO-
Pudenz-Schulte Medical Research Corp.
Neurology
20d
Cleared
Mar 01, 1982
H-H RICKHAM TYPE RESERVOIR
Holter-Hausner Intl.
Neurology
24d
Cleared
Feb 24, 1982
H-H BURR HOLE CATHETER SUPPORT
Holter-Hausner Intl.
Neurology
19d
Cleared
Jan 22, 1981
CSG-FLOW CONTROL VALVE
Pudenz-Schulte Medical Research Corp.
Neurology
30d
Cleared
Jan 31, 1980
H-H FIFTH VENTRICLE
Holter-Hausner Intl.
Neurology
6d
Cleared
Jan 16, 1980
CSF-CARDIAC/PERITONEAL CATHETER
Pudenz-Schulte Medical Research Corp.
Neurology
103d
Cleared
Jan 16, 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
Pudenz-Schulte Medical Research Corp.
Neurology
103d
Cleared
Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
Holter-Hausner Intl.
Neurology
52d