FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K003759 |
AESCULAP, INC. |
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR |
06/28/2001 |
K201989 |
Braincare Desenvolvimento e Inovacao Tecnologica S.A. |
B4C System |
10/08/2021 |
K182073 |
Braincare desenvolvimento e Inovacao Tecnologica S.A. |
BcSs-PICNI-2000 Sensor |
10/17/2019 |
K172209 |
Branchpoint Technologies, INC. |
AURA ICP MONITORING SYSTEM |
05/18/2018 |
K962928 |
CAMINO NEUROCARE, INC. |
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) |
12/20/1996 |
K981846 |
CAMINO NEUROCARE, INC. |
PARENCHYMAL BOLT PRESSURE MONITORING KIT |
08/18/1998 |
K982702 |
CAMINO NEUROCARE, INC. |
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD |
09/10/1998 |
K020285 |
CMA MICRODIALYSIS AB |
CMA CEREBRAL TISSUE MONITORING SYSTEM |
10/23/2002 |
K060554 |
CMA MICRODIALYSIS AB |
CMA CEREBRAL TISSUE MONITORING SYSTEM |
05/02/2006 |
K071984 |
CMA MICRODIALYSIS AB |
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM |
06/27/2008 |
K102077 |
CMA MICRODIALYSIS AB |
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM |
01/14/2011 |
K173192 |
Codman & Shurtleff, Inc |
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit |
11/08/2017 |
K153347 |
CODMAN & SHURTLEFF, INC. |
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit |
08/19/2016 |
K992591 |
Codman & Shurtleff, Inc. |
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS |
10/15/1999 |
K980380 |
DIAMETRICS MEDICAL, LTD. |
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS |
07/14/1999 |
K101133 |
DPCOM AS |
SENSOMETRICS SOFTWARE |
11/18/2010 |
K032337 |
HEMEDEX INCORPORATED |
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 |
10/21/2003 |
K141869 |
HEMEDEX INCORPORATED |
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT |
10/10/2014 |
K161010 |
InnerSpace Neuro Solutions, Inc. |
HICP200 Patient/Monitor Interconnect Cable |
10/20/2016 |
K113088 |
INNERSPACE, INC |
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) |
05/02/2012 |
K010422 |
INNERSPACE, INC. |
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER |
06/28/2001 |
K013705 |
INNERSPACE, INC. |
ACT III VENTRICULAR CATHETER |
09/09/2002 |
K003905 |
INNERSPACE, INC. |
ACTI-ICP MONITORING SYSTEM |
06/15/2001 |
K041838 |
INNERSPACE, INC. |
MPS (OR MPS-T) |
03/01/2005 |
K072379 |
INNERSPACE, INC. |
MPS OXIPORT AND MPS OXIPORT PLUS |
04/29/2008 |
K083378 |
INNERSPACE, INC. |
SYNERGY |
09/29/2009 |
K121159 |
INTEGRA LIFESCIENCE CORPORTATION |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER |
07/20/2012 |
K183406 |
Integra LifeSciences Corp. |
CereLink ICP Monitor, CereLink ICP Extension Cable |
01/11/2019 |
K131184 |
INTEGRA LIFESCIENCES CORP. |
INTEGRA LICOX PTO2 MONITOR |
08/30/2013 |
K053244 |
INTEGRA LIFESCIENCES CORP. |
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT |
05/10/2006 |
K102875 |
INTEGRA LIFESCIENCES CORPORATION |
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C |
12/20/2010 |
K133754 |
INTEGRA LIFESCIENCES CORPORATION |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER |
03/06/2014 |
K061640 |
INTEGRA LIFESCIENCES CORPORATION |
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM |
07/27/2006 |
K040235 |
INTEGRA LIFESCIENCES CORPORATION |
LICOX PMO BRAIN MONITORING SYSTEM |
04/20/2004 |
K071505 |
INTEGRA LIFESCIENCES CORPORATION |
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM |
08/06/2007 |
K210993 |
Integra LifeSciences Production Corporation |
CereLink ICP Monitor |
04/30/2021 |
K031086 |
INTEGRA NEURO SCIENCES |
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 |
05/14/2003 |
K002392 |
INTEGRA NEUROCARE LLC. |
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V |
11/02/2000 |
K022553 |
INTEGRA NEUROSCIENCES |
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L |
08/20/2002 |
K020558 |
INTEGRA NEUROSCIENCES |
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE |
03/21/2002 |
K002765 |
INTEGRA NEUROSCIENCES |
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE |
11/24/2000 |
K050720 |
INTEGRA NEUROSCIENCES |
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 |
05/11/2005 |
K121573 |
INTRGRA LIFESCIENCES CORPORATION |
INTEGRA CAMINO ICP MONITOR |
09/10/2012 |
K974088 |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
CODMAN INTRACRANIAL BOLT |
01/09/1998 |
K991222 |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT |
07/09/1999 |
K020780 |
MEDEX, INC. |
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP |
05/20/2002 |
K152670 |
Medos International SARL |
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables |
01/22/2016 |
K983799 |
MEDTRONIC PS MEDICAL |
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL |
01/26/1999 |
K200456 |
Medtronic, Inc. |
Becker External Drainage and Monitoring System |
03/26/2020 |
K201118 |
Medtronic, Inc. |
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level |
05/26/2020 |
K200630 |
Medtronic, Inc. |
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags |
04/09/2020 |
K022638 |
NEURORECOVERY, INC. |
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT |
10/31/2002 |
K051599 |
NEURORECOVERY, INC. |
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT |
07/19/2005 |
K050702 |
NEUROSYSTEMS LLC |
NEUROSYSTEMS 1TM MONITOR |
05/17/2005 |
K042728 |
NOVUS MONITORING LTD |
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM |
10/22/2004 |
K013930 |
NOVUS MONITORING LTD |
NEUROSENSOR |
02/20/2002 |
K171666 |
Raumedic AG |
MPR2 logO DATALOGGER |
07/06/2017 |
K112017 |
RAUMEDIC AG |
RAUMEDIC ICP MONITORING SYSTEM |
10/11/2011 |
K103206 |
RAUMEDIC AG |
RAUMEDIC- ICP-MONITORING SYSTEM |
03/04/2011 |
K120252 |
RAUMEDIC AG |
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM |
04/11/2012 |
K130529 |
RAUMEDIC AG |
RAUMEDIC-PTO-MONITORING-SYSTEM |
10/25/2013 |
K062584 |
SOPHYSA SA |
PRESSIO ICP MONITORING SYSTEM |
07/05/2007 |
K162108 |
SOPHYSA, SA |
Pressio 2 ICP Monitoring System |
04/17/2017 |