FDA 510(k) Applications for Medical Device Product Code "JXG"
(Shunt, Central Nervous System And Components)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K161853 | AESCULAP INC. | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | 02/27/2017 |
| K141687 | AESCULAP, INC. | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | 04/02/2015 |
| K030698 | AESCULAP, INC. | AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV | 03/20/2003 |
| K011030 | AESCULAP, INC. | AESCULAP -MIETHKE SHUNT SYSTEM | 03/01/2002 |
| K103003 | AESCULAP, INC. | AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM | 11/09/2010 |
| K110206 | AESCULAP, INC. | AESCULAP- MEITHKE SHUNT SYSTEM | 10/27/2011 |
| K062009 | AESCULAP, INC. | AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T | 01/17/2007 |
| K120559 | AESCULAP, INC. | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM | 05/24/2012 |
| K031303 | AESCULAP, INC. | AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) | 06/04/2003 |
| K192266 | Aesculap, Inc. | M. Blue Adjustable Shunt System | 11/21/2019 |
| K190174 | Aesculap, Inc. | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | 07/05/2019 |
| K200950 | Aesculap, Inc. | Ventricular Catheter | 05/08/2020 |
| K172006 | Alcyone Lifesciences. Inc. | Alivio Ventricular Catheter and Flusher System (Alivio System) | 11/09/2017 |
| K221918 | Anuncia Medical, Inc. | ReFlow System Mini | 09/29/2022 |
| K223603 | Anuncia Medical, Inc. | Reflow System Mini and ReFlow Mini Flusher | 12/29/2022 |
| K171586 | Aqueduct Critical Care, Inc | Smart External Drain (SED) System | 06/30/2017 |
| K161605 | AQUEDUCT CRITICAL CARE, INC. | Smart External Drain (SED) System | 10/27/2016 |
| K172759 | Aqueduct Critical Care, Inc. | Smart External Drain (SED) System | 11/14/2017 |
| K181301 | Aqueduct Critical Care, Inc. | Smart External Drain (SED) System | 06/14/2018 |
| K170599 | Arkis BioSciences Inc. | SureFlo EVD Catheter | 08/31/2017 |
| K984583 | BIOMEDICS | THE BIOPLATE SHUNT CONNECTOR | 03/15/1999 |
| K172035 | BTG International, Inc. | EKOS ultrasound EVD Device, EVD Control Unit | 03/24/2018 |
| K102589 | Codman & Shurtleff, Inc. | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER | 01/14/2011 |
| K110751 | Codman & Shurtleff, Inc. | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER | 05/09/2011 |
| K021653 | Codman & Shurtleff, Inc. | CODMAN BACTISEAL EVD CATHETER SET | 07/29/2002 |
| K090348 | Codman & Shurtleff, Inc. | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET | 03/04/2009 |
| K172537 | Codman & Shurtleff, Inc. | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | 10/16/2017 |
| K061568 | Codman & Shurtleff, Inc. | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 | 09/29/2006 |
| K162437 | Codman & Shurtleff, Inc. | Codman EDS3 CSF External Drainage System | 10/28/2016 |
| K091346 | Codman & Shurtleff, Inc. | CODMAN HAKIM MICRO II VALVE | 06/02/2009 |
| K053107 | Codman & Shurtleff, Inc. | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD | 01/19/2006 |
| K020667 | Codman & Shurtleff, Inc. | CODMAN HAKIM SHUNT SYSTEMS | 03/28/2002 |
| K172022 | Codman & Shurtleff, Inc. | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | 10/03/2017 |
| K050739 | Codman & Shurtleff, Inc. | CODMAN VPV SYSTEM, MODEL 82-3192 | 07/18/2005 |
| K061876 | Codman & Shurtleff, Inc. | CODMAN VPV SYSTEM, MODEL 82-3192 | 10/16/2006 |
| K122118 | Codman & Shurtleff, Inc. | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | 08/03/2012 |
| K003564 | Codman & Shurtleff, Inc. | HAKIM PROGRAMMER AND TRANSMITTER | 12/20/2000 |
| K102961 | Codman & Shurtleff, Inc. | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM | 02/18/2011 |
| K053350 | Codman & Shurtleff, Inc. | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS | 01/19/2006 |
| K041296 | Codman & Shurtleff, Inc. | MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI | 06/10/2004 |
| K962097 | COOK, INC. | VENTRICULAR CATHETER SET | 08/29/1996 |
| K955265 | CORDIS CORP. | CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER | 12/20/1996 |
| K960159 | CORDIS CORP. | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) | 10/25/1996 |
| K955832 | CORDIS CORP. | CORDIS VENTRICULAR ANTECHAMBER (VA) | 03/25/1996 |
| K971799 | ELEKTA IMPLANTS, SA | PRECISION FLOW OSV II | 02/06/1998 |
| K974726 | ELEKTA IMPLANTS, SA | SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER | 03/18/1998 |
| K030081 | INMED LTDA. | CSF400 AND CSF600 | 10/06/2003 |
| K181902 | Integra LifeSciences Corp. | Codman Certas Plus Electronic Tool Kit | 10/25/2018 |
| K182265 | Integra LifeSciences Corp. | CodMan Certas Plus Programmable Valve | 11/20/2018 |
| K030289 | INTEGRA LIFESCIENCES CORP. | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N | 02/26/2003 |
| K092395 | INTEGRA LIFESCIENCES CORP. | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | 11/19/2009 |
| K042825 | INTEGRA LIFESCIENCES CORPORATION | ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM | 12/21/2004 |
| K153041 | INTEGRA LIFESCIENCES CORPORATION | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | 03/14/2016 |
| K101381 | INTEGRA LIFESCIENCES CORPORATION | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS | 07/07/2011 |
| K161992 | INTEGRA LIFESCIENCES CORPORATION | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | 09/22/2016 |
| K152897 | INTEGRA LIFESCIENCES CORPORATION | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | 03/04/2016 |
| K140722 | INTEGRA LIFESCIENCES CORPORATION | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | 01/06/2015 |
| K072929 | INTEGRA LIFESCIENCES CORPORATION | LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 | 12/07/2007 |
| K191684 | Integra Lifesciences Corporation | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | 10/11/2019 |
| K062599 | INTEGRA LIFESCIENCES CORPORATION | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS | 09/27/2006 |
| K093968 | INTEGRA LIFESCIENCES CORPORATION | OSV II LOW FLOW LOW PRO VALVE | 01/22/2010 |
| K223330 | Integra LifeSciences Production Corporation | Certas Plus Programmable Valves | 02/01/2023 |
| K221840 | Integra LifeSciences Production Corporation | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | 10/14/2022 |
| K981246 | INTEGRA NEUROCARE LLC. | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) | 05/26/1999 |
| K971617 | INTEGRA NEUROCARE LLC. | ENDOSCOPIC VENTRICULAR CATHETER | 07/31/1997 |
| K972994 | INTEGRA NEUROCARE LLC. | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | 11/03/1997 |
| K970658 | INTEGRA NEUROCARE LLC. | LUMBAR DRAINAGE ACCESSORY KIT | 05/19/1997 |
| K973525 | INTEGRA NEUROCARE LLC. | MAURICE WORLDWIDE SHUNT SYSTEM | 12/16/1997 |
| K961859 | INTEGRA NEUROCARE LLC. | NOVUS STANDARD AND PEDIATRIC VALVES | 12/16/1996 |
| K970983 | INTEGRA NEUROCARE LLC. | PERITONEAL/CARDIAC CATHETER | 06/13/1997 |
| K963802 | INTEGRA NEUROCARE LLC. | SHUNT TAP | 12/12/1996 |
| K964371 | INTEGRA NEUROCARE LLC. | SHUNT TAP WITH ICP MONITORING ACCESS PORT | 01/31/1997 |
| K022554 | INTEGRA NEUROSCIENCES | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | 08/23/2002 |
| K033698 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | CONTOUR-FLEX VALVE AND SHUNT SYSTEM | 12/17/2003 |
| K042558 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | EQUI-FLOW VALVE AND SHUNT SYSTEM | 10/06/2004 |
| K032817 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | EXTERNAL DRAINAGE SET | 10/06/2003 |
| K042192 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | LOW FLOW OSV II HYDROCEPHALUS VALVE | 09/02/2004 |
| K040201 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM | 02/26/2004 |
| K081773 | INTEGRA NEUROSCIENCES IMPLANTS S.A. | OSV II | 11/06/2008 |
| K171880 | IRRAS Inc. | IRRAflow CNS System | 07/13/2018 |
| K222471 | IRRAS USA | IRRAflow Active Fluid Exchange System (AFES) | 12/08/2022 |
| K200807 | IRRAS USA Inc. | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | 04/29/2020 |
| K192289 | IRRAS USA, Ltd. | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | 11/15/2019 |
| K221694 | JMED(Shenzhen) Technology Limited | External Drainage System | 02/09/2023 |
| K973774 | JOHNSON & JOHNSON PROFESSIONALS, INC. | CODMAN HAKIM MICRO PRECISION VALVE | 12/29/1997 |
| K964923 | JOHNSON & JOHNSON PROFESSIONALS, INC. | CODMAN LUMBAR DRAINAGE CATHETER KIT | 06/25/1997 |
| K980778 | JOHNSON & JOHNSON PROFESSIONALS, INC. | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | 07/17/1998 |
| K974739 | JOHNSON & JOHNSON PROFESSIONALS, INC. | HAKIM PROGRAMMABLE VALVE SYSTEM | 07/01/1998 |
| K992173 | JOHNSON & JOHNSON PROFESSIONALS, INC. | SIPHONGUARD CSF CONTROL DEVICE | 04/07/2000 |
| K002970 | MEDICAL DESIGNS L.L.C. | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 | 12/12/2000 |
| K042359 | MEDICAL DESIGNS, LLC | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL | 11/17/2004 |
| K152152 | Medos International Sarl | Codman Certas Plus Programmable Valve | 10/27/2015 |
| K143111 | MEDOS INTERNATIONAL SARL | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | 02/19/2015 |
| K113526 | MEDOS INTERNATIONAL SARL | CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM | 02/16/2012 |
| K112156 | MEDOS INTERNATIONAL SARL | CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM | 10/17/2011 |
| K110560 | MEDTRONIC NEUROSURGERY | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER | 11/18/2011 |
| K052386 | MEDTRONIC NEUROSURGERY | MEDTRONIC M2 MAGNET ADJUSTMENT TOOL | 12/16/2005 |
| K033850 | MEDTRONIC NEUROSURGERY | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE | 01/13/2004 |
| K060681 | MEDTRONIC NEUROSURGERY | MEDTRONIC PS MEDICAL STRATA TYPE VALUE | 09/15/2006 |
| K040943 | MEDTRONIC NEUROSURGERY | MEDTRONIC PS MEDICAL STRATA VALVE | 06/15/2004 |
| K123524 | MEDTRONIC NEUROSURGERY | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | 02/13/2013 |
| K041992 | MEDTRONIC NEUROSURGERY | MEDTRONIC STRATAVARIUS | 01/28/2005 |
| K042198 | MEDTRONIC NEUROSURGERY | PS MEDICAL NEUROSURGICAL IMPLANTS | 09/24/2004 |
| K042465 | MEDTRONIC NEUROSURGERY | PS MEDICAL STRATA II VALVE | 10/19/2004 |
| K091312 | MEDTRONIC NEUROSURGERY | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | 09/02/2009 |
| K063836 | MEDTRONIC NEUROSURGERY | RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 | 08/16/2007 |
| K073139 | MEDTRONIC NEUROSURGERY | SMALL LUMEN PERITONEAL CATHETER | 01/30/2008 |
| K083076 | MEDTRONIC NEUROSURGERY | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 | 11/20/2008 |
| K082127 | MEDTRONIC NEUROSURGERY | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 | 08/27/2008 |
| K181622 | Medtronic Neurosurgery | StrataMR guider tool | 10/01/2018 |
| K212641 | Medtronic Neurosurgery | StrataMR II Valves and Shunts | 09/16/2021 |
| K152700 | MEDTRONIC NEUROSURGERY | StrataMR Valves and Shunts | 04/07/2016 |
| K984053 | MEDTRONIC PS MEDICAL | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM | 02/04/1999 |
| K981046 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 | 06/16/1998 |
| K991502 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 | 09/12/2000 |
| K012052 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 | 02/11/2002 |
| K150898 | MOLLER MEDICAL GMBH | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | 12/18/2015 |
| K121248 | MOLLER MEDICAL GMBH | LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC | 12/13/2013 |
| K080168 | NEURO DIAGNOSTIC DEVICES | SHUNTCHECK - CSF SHUNT FLOW DETECTOR | 05/16/2008 |
| K974708 | NEUROCARE GROUP | GEMINI STANDARD AND MINI VALVES | 03/10/1998 |
| K123554 | NEURODX DEVELOPMENT LLC | SHUNTCHECK | 03/07/2013 |
| K021196 | NEURON THERAPEUTICS, INC. | NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 | 07/01/2002 |
| K990660 | NMT NEUROSCIENCES IMPLANTS S.A. | NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX | 09/23/1999 |
| K033017 | PHOENIX BIOMEDICAL | PHOENIX INFUSION CATHETER | 04/07/2004 |
| K024040 | PHOENIX BIOMEDICAL CORP. | ACCURA ELITE SHUNT SYSTEM | 01/27/2003 |
| K030468 | PHOENIX BIOMEDICAL CORP. | ACURA ELITE GRAVITY COMPENSATING RESERVOIR | 10/15/2003 |
| K974096 | PHOENIX BIOMEDICAL CORP. | CRX DIAMOND VALVE | 12/08/1998 |
| K990256 | PHOENIX BIOMEDICAL CORP. | CRX WORLD SHUNT | 04/01/1999 |
| K991429 | PHOENIX BIOMEDICAL CORP. | DIAMOND II VALVE | 05/19/1999 |
| K002476 | PHOENIX BIOMEDICAL CORP. | LUMBOPERITONEAL SHUNT SYSTEM | 11/09/2000 |
| K021644 | PHOENIX BIOMEDICAL CORP. | PERF (OMMAYA STYLE) RESERVOIRS | 08/06/2002 |
| K960435 | PHOENIX BIOMEDICAL CORP. | PHOENIX CRX VALVE | 08/27/1996 |
| K024101 | PHOENIX BIOMEDICAL CORP. | PHOENIX UNIVERSAL SHUNT SYSTEM | 01/27/2003 |
| K000514 | PHOENIX BIOMEDICAL CORP. | RUMBAR DRAINAGE SYSTEM | 05/10/2000 |
| K954285 | RADIONICS, INC. | CONTOUR FLEX VALVES (REGULAR & SMALL) | 01/26/1996 |
| K970578 | RADIONICS, INC. | RADIONICS BURR HOLE VALVE | 06/04/1997 |
| K964386 | RADIONICS, INC. | RADIONICS CONTOUR FLEX PLUS VALVE | 01/31/1997 |
| K971511 | RADIONICS, INC. | RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE | 07/24/1997 |
| K980903 | RADIONICS, INC. | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT | 04/19/1999 |
| K000057 | RADIONICS, INC. | RADIONICS LUMBOPERITONEAL SHUNT | 03/20/2000 |
| K962990 | RADIONICS, INC. | RADIONICS SIPHON LIMITING DEVICE (SLD) | 10/23/1996 |
| K992379 | RADIONICS, INC. | RADIONICS XDC EXTERNAL VENTRICULAR CATHETER | 09/08/1999 |
| K992226 | RADIONICS, INC. | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | 08/04/2000 |
| K040021 | SAMUEL NEFF M.D. | SHUNTCHECK (PROMETHEUS 1) | 11/02/2004 |
| K222422 | Sophysa | Polaris Valve Electronic Reading Instrument | 02/02/2023 |
| K031097 | SOPHYSA SA | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB | 02/26/2004 |
| K042481 | SOPHYSA SA | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 | 12/14/2004 |
| K141227 | SOPHYSA SA | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX | 04/02/2015 |
| K090342 | SOPHYSA SA | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | 08/11/2009 |
| K091328 | SOPHYSA SA | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | 01/22/2010 |
| K013488 | SOPHYSA SA | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | 03/27/2002 |
| K992465 | SOPHYSA SA | SOPHY SU8 PRESSURE ADJUSTABLE VALVE | 09/21/2000 |
| K081942 | VYGON NEURO | NEUROCATH AG | 08/12/2008 |
| K033704 | VYGON US LLC | MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS | 05/27/2004 |
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