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
169–192 of 260
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 Mar 30, 1995
CAMINO VENTRICULAR DRAINAGE SYSTEM
K932769
Camino Laboratories, Inc.
Neurology · 660d
Cleared Nov 07, 1994
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
K935560
Pmt Corp.
Neurology · 355d
Cleared Jul 20, 1994
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429
Cordis Corp.
Neurology · 426d
Cleared Apr 28, 1994
PS MEDICAL DELTA BURR HOLE VALVE
K934545
Pudenz-Schulte Medical Research Corp.
Neurology · 218d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810
Cordis Corp.
Neurology · 470d
Cleared Jul 21, 1993
VENTRI-CATH
K931989
Gesco Intl., Inc.
Neurology · 90d
Cleared Apr 15, 1993
CAMINO VENTRICULAR ACCESS DEVICE
K930222
Camino Laboratories, Inc.
Neurology · 90d
Cleared Mar 30, 1993
PS MEDICAL CSF-ACCESS DEVICE
K913412
Pudenz-Schulte Medical Research Corp.
Neurology · 608d
Cleared Dec 10, 1992
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600
Cordis Corp.
Neurology · 90d
Cleared Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K921936
Cordis Corp.
Neurology · 189d
Cleared Aug 26, 1992
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE
K922936
Clinical Neuro Systems, LLC
Neurology · 69d
Cleared Aug 26, 1992
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
K922941
Clinical Neuro Systems, LLC
Neurology · 69d
Cleared Mar 16, 1992
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
K920156
Clinical Neuro Systems, LLC
Neurology · 62d
Cleared Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995
Cordis Corp.
Neurology · 123d
Cleared Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842
Cordis Corp.
Neurology · 175d
Cleared Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636
Cordis Corp.
Neurology · 119d
Cleared Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433
Cordis Corp.
Neurology · 167d
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860
Baxter Healthcare Corp
Neurology · 263d
Cleared Aug 16, 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938
Codman & Shurtleff, Inc.
Neurology · 163d