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..

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
73–96 of 259
Cleared Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
K003564
Codman & Shurtleff, Inc.
Neurology · 30d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226
Radionics, Inc.
Neurology · 399d
Cleared Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173
Johnson & Johnson Professionals, Inc.
Neurology · 284d
Cleared Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057
Radionics, Inc.
Neurology · 70d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379
Radionics, Inc.
Neurology · 54d
Cleared Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903
Radionics, Inc.
Neurology · 405d
Cleared Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778
Johnson & Johnson Professionals, Inc.
Neurology · 137d
Cleared Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739
Johnson & Johnson Professionals, Inc.
Neurology · 194d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774
Johnson & Johnson Professionals, Inc.
Neurology · 87d
Cleared Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511
Radionics, Inc.
Neurology · 87d
Cleared Jun 25, 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923
Johnson & Johnson Professionals, Inc.
Neurology · 198d
Cleared Jun 04, 1997
RADIONICS BURR HOLE VALVE
K970578
Radionics, Inc.
Neurology · 110d
Cleared Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
K964386
Radionics, Inc.
Neurology · 88d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265
Cordis Corp.
Neurology · 402d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159
Cordis Corp.
Neurology · 288d
Cleared Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990
Radionics, Inc.
Neurology · 83d
Cleared Aug 29, 1996
VENTRICULAR CATHETER SET
K962097
Cook, Inc.
Neurology · 92d
Cleared Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832
Cordis Corp.
Neurology · 90d
Cleared Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
K954285
Radionics, Inc.
Neurology · 134d
Cleared Oct 24, 1995
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021
Johnson & Johnson Professionals, Inc.
Neurology · 85d
Cleared Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595
Cordis Corp.
Neurology · 395d
Cleared Sep 18, 1995
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K951258
Pudenz-Schulte Medical Research Corp.
Neurology · 181d
Cleared Jul 28, 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222
Johnson & Johnson Professionals, Inc.
Neurology · 332d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429
Cordis Corp.
Neurology · 426d