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 Pudenz-Schulte Medical Research Corp..

260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
241–260 of 260
Cleared Dec 16, 1982
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K823509
Pudenz-Schulte Medical Research Corp.
Neurology · 20d
Cleared Mar 01, 1982
H-H RICKHAM TYPE RESERVOIR
K820312
Holter-Hausner Intl.
Neurology · 24d
Cleared Feb 24, 1982
H-H BURR HOLE CATHETER SUPPORT
K820311
Holter-Hausner Intl.
Neurology · 19d
Cleared Feb 18, 1982
EXTERNAL VENTRICULAR DRAINAGE SYS.
K820247
American Heyer Schulte
Neurology · 20d
Cleared Jun 26, 1981
SPETZLER LUMBAR-PERITONEAL SYSTEM
K811288
American Heyer Schulte
Neurology · 46d
Cleared Jan 22, 1981
CSG-FLOW CONTROL VALVE
K803257
Pudenz-Schulte Medical Research Corp.
Neurology · 30d
Cleared Dec 18, 1980
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
K802586
American Heyer Schulte
Neurology · 59d
Cleared Jan 31, 1980
H-H FIFTH VENTRICLE
K800168
Holter-Hausner Intl.
Neurology · 6d
Cleared Jan 16, 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Jan 16, 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
K791075
Holter-Hausner Intl.
Neurology · 52d
Cleared Aug 03, 1979
H-H SLOTTED VENTRICULAR CATHETER
K791076
Holter-Hausner Intl.
Neurology · 52d
Cleared May 11, 1979
H-H FIXATION AND JOINING CONNECTORS
K790849
Holter-Hausner Intl.
Neurology · 8d
Cleared Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
K790126
Holter-Hausner Intl.
Neurology · 2d
Cleared Jan 15, 1979
CATHETERS, H-H VENTRICULAR
K782105
Holter-Hausner Intl.
Neurology · 27d
Cleared Nov 14, 1978
CATHETERS, H-H ATRIAL AND PERITONEAL
K781768
Holter-Hausner Intl.
Neurology · 29d
Cleared Nov 01, 1976
MISHLER 2 CHAMB FLUSHING VALVE,STAND
K760784
Heyer Schulte Corp.
Neurology · 27d
Cleared Nov 01, 1976
MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH
K760785
Heyer Schulte Corp.
Neurology · 27d
Cleared Aug 30, 1976
VALVE, STANDARD MODEL PUDENZE FLUSHING
K760501
Heyer Schulte Corp.
Neurology · 7d
Cleared Aug 30, 1976
VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.
K760502
Joe W. Utt
Neurology · 7d