Shunt, Central Nervous System And Components
Regulation 882.5550
4510(k)s in 12 months (260 all time)
1recalls in 12 months (108 all time)
103recalls that name a 510(k)
Top companies in JXG
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neurosurgery | 18 | 49 |
| Codman & Shurtleff, Inc. | 23 | 19 |
| Integra LifeSciences Corporation | 14 | 21 |
| Holter-Hausner Intl. | 21 | 0 |
| Aesculap, Inc. | 14 | 6 |
| Cordis Corp. | 18 | 0 |
| Pudenz-Schulte Medical Research Corp. | 18 | 0 |
| Phoenix Biomedical | 11 | 1 |
| Radionics, Inc. | 10 | 0 |
| Sophysa | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2015 | K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Apr 2, 2015 | K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX Sophysa SA | JXG |
| Feb 19, 2015 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit Medos International SARL, CH | JXG |
| Jan 6, 2015 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS Integra LifeSciences Corporation | JXG |
| Dec 13, 2013 | K121248 | LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC Moller Medical GmbH | JXG |
| Mar 7, 2013 | K123554 | SHUNTCHECK Neurodx Development, LLC | JXG |
| Feb 13, 2013 | K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery | JXG |
| Aug 3, 2012 | K122118 | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM Codman & Shurtleff, Inc. | JXG |
| May 24, 2012 | K120559 | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Feb 16, 2012 | K113526 | CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM Medos International SARL | JXG |
| Nov 18, 2011 | K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER Medtronic Neurosurgery | JXG |
| Oct 27, 2011 | K110206 | AESCULAP- MEITHKE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Oct 17, 2011 | K112156 | CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM Medos International SARL | JXG |
| Jul 7, 2011 | K101381 | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS Integra LifeSciences Corporation | JXG |
| May 9, 2011 | K110751 | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER Codman & Shurtleff, Inc. | JXG |
| Feb 18, 2011 | K102961 | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM Codman & Shurtleff, Inc. | JXG |
| Jan 14, 2011 | K102589 | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER Codman & Shurtleff, Inc. | JXG |
| Nov 9, 2010 | K103003 | AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Jan 22, 2010 | K093968 | OSV II LOW FLOW LOW PRO VALVE Integra LifeSciences Corporation | JXG |
| Jan 22, 2010 | K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE Sophysa SA | JXG |
| Nov 19, 2009 | K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM Integra Lifesciences Corp. | JXG |
| Sep 2, 2009 | K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery | JXG |
| Aug 11, 2009 | K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 Sophysa SA | JXG |
| Jun 2, 2009 | K091346 | CODMAN HAKIM MICRO II VALVE Codman & Shurtleff, Inc. | JXG |
| Mar 4, 2009 | K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET Codman & Shurtleff, Inc. | JXG |
| Nov 20, 2008 | K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 Medtronic Neurosurgery | JXG |
| Nov 6, 2008 | K081773 | OSV II Integra Neurosciences Implants S.A. | JXG |
| Aug 27, 2008 | K082127 | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 Medtronic Neurosurgery | JXG |
| Aug 12, 2008 | K081942 | NEUROCATH AG Vygon Neuro | JXG |
| May 16, 2008 | K080168 | SHUNTCHECK - CSF SHUNT FLOW DETECTOR Neuro Diagnostic Devices | JXG |
| Jan 30, 2008 | K073139 | SMALL LUMEN PERITONEAL CATHETER Medtronic Neurosurgery | JXG |
| Dec 7, 2007 | K072929 | LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 Integra LifeSciences Corporation | JXG |
| Aug 16, 2007 | K063836 | RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 Medtronic Neurosurgery | JXG |
| Jan 17, 2007 | K062009 | AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T Aesculap, Inc. | JXG |
| Oct 16, 2006 | K061876 | CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. | JXG |
| Sep 29, 2006 | K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 Codman & Shurtleff, Inc. | JXG |
| Sep 27, 2006 | K062599 | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS Integra LifeSciences Corporation | JXG |
| Sep 15, 2006 | K060681 | MEDTRONIC PS MEDICAL STRATA TYPE VALUE Medtronic Neurosurgery | JXG |
| Jan 19, 2006 | K053350 | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. | JXG |
| Jan 19, 2006 | K053107 | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD Codman & Shurtleff, Inc. | JXG |
| Dec 16, 2005 | K052386 | MEDTRONIC M2 MAGNET ADJUSTMENT TOOL Medtronic Neurosurgery | JXG |
| Jul 18, 2005 | K050739 | CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. | JXG |
| Jan 28, 2005 | K041992 | MEDTRONIC STRATAVARIUS Medtronic Neurosurgery | JXG |
| Dec 21, 2004 | K042825 | ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM Integra LifeSciences Corporation | JXG |
| Dec 14, 2004 | K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 Sophysa SA | JXG |
| Nov 17, 2004 | K042359 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL Medical Designs, LLC | JXG |
| Nov 2, 2004 | K040021 | SHUNTCHECK (PROMETHEUS 1) Samuel Neff M.D. | JXG |
| Oct 19, 2004 | K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery | JXG |
| Oct 6, 2004 | K042558 | EQUI-FLOW VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. | JXG |
| Sep 24, 2004 | K042198 | PS MEDICAL NEUROSURGICAL IMPLANTS Medtronic Neurosurgery | JXG |
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