GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Innerspace, Inc. and Raumedic AG.

105
Total
105
Cleared
149d
Avg days
1978
Since
105 devices
49–72 of 105
Cleared Oct 23, 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285
Cma Microdialysis AB
Neurology · 268d
Cleared Sep 09, 2002
ACT III VENTRICULAR CATHETER
K013705
Innerspace, Inc.
Neurology · 305d
Cleared Aug 20, 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
K022553
Integra Neurosciences
Neurology · 18d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780
Medex, Inc.
Neurology · 70d
Cleared Mar 21, 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558
Integra Neurosciences
Neurology · 29d
Cleared Feb 20, 2002
NEUROSENSOR
K013930
Novus Monitoring, Ltd.
Neurology · 84d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759
Aesculap, Inc.
Neurology · 204d
Cleared Jun 28, 2001
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
K010422
Innerspace, Inc.
Neurology · 136d
Cleared Jun 15, 2001
ACTI-ICP MONITORING SYSTEM
K003905
Innerspace, Inc.
Neurology · 178d
Cleared Nov 24, 2000
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
K002765
Integra Neurosciences
Neurology · 80d
Cleared Nov 02, 2000
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K002392
Integra Neurocare, LLC
Neurology · 87d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591
Codman & Shurtleff, Inc.
Neurology · 74d
Cleared Jul 14, 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K980380
Diametrics Medical, Ltd.
Neurology · 527d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222
Johnson & Johnson Professionals, Inc.
Neurology · 88d
Cleared Jan 26, 1999
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
K983799
Medtronic PS Medical
Neurology · 90d
Cleared Sep 10, 1998
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K982702
Camino Neurocare, Inc.
Neurology · 38d
Cleared Aug 18, 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846
Camino Neurocare, Inc.
Neurology · 84d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088
Johnson & Johnson Professionals, Inc.
Neurology · 71d
Cleared Dec 20, 1996
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K962928
Camino Neurocare, Inc.
Neurology · 144d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585
Johnson & Johnson Professionals, Inc.
Neurology · 346d
Cleared Sep 26, 1995
CHARTR ENG SYSTEM
K931609
Ics Medical Corp.
Neurology · 908d
Cleared Mar 01, 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648
Cordis Corp.
Neurology · 379d
Cleared Dec 07, 1994
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
K943987
Innerspace Medical, Inc.
Neurology · 113d
Cleared Mar 07, 1994
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479
Codman & Shurtleff, Inc.
Neurology · 881d