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 Pudenz-Schulte Medical Research Corp..
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
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
Cleared
Aug 03, 1979
H-H SLOTTED VENTRICULAR CATHETER
Holter-Hausner Intl.
Neurology
52d
Cleared
May 11, 1979
H-H FIXATION AND JOINING CONNECTORS
Holter-Hausner Intl.
Neurology
8d
Cleared
Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
Holter-Hausner Intl.
Neurology
2d
Cleared
Jan 15, 1979
CATHETERS, H-H VENTRICULAR
Holter-Hausner Intl.
Neurology
27d
Cleared
Nov 14, 1978
CATHETERS, H-H ATRIAL AND PERITONEAL
Holter-Hausner Intl.
Neurology
29d