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 |
|---|---|---|---|
| Sep 2, 2004 | K042192 | LOW FLOW OSV II HYDROCEPHALUS VALVE Integra Neurosciences Implants S.A. | JXG |
| Jun 15, 2004 | K040943 | MEDTRONIC PS MEDICAL STRATA VALVE Medtronic Neurosurgery | JXG |
| Jun 10, 2004 | K041296 | MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI Codman & Shurtleff, Inc. | JXG |
| May 27, 2004 | K033704 | MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS Vygon Us, LLC | JXG |
| Apr 7, 2004 | K033017 | PHOENIX INFUSION CATHETER Phoenix Biomedical | JXG |
| Feb 26, 2004 | K040201 | MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. | JXG |
| Feb 26, 2004 | K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB Sophysa SA | JXG |
| Jan 13, 2004 | K033850 | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE Medtronic Neurosurgery | JXG |
| Dec 17, 2003 | K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. | JXG |
| Oct 15, 2003 | K030468 | ACURA ELITE GRAVITY COMPENSATING RESERVOIR Phoenix Biomedical Corp. | JXG |
| Oct 6, 2003 | K032817 | EXTERNAL DRAINAGE SET Integra Neurosciences Implants S.A. | JXG |
| Oct 6, 2003 | K030081 | CSF400 AND CSF600 Inmed Ltda. | JXG |
| Jun 4, 2003 | K031303 | AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) Aesculap, Inc. | JXG |
| Mar 20, 2003 | K030698 | AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV Aesculap, Inc. | JXG |
| Feb 26, 2003 | K030289 | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N Integra Lifesciences Corp. | JXG |
| Jan 27, 2003 | K024101 | PHOENIX UNIVERSAL SHUNT SYSTEM Phoenix Biomedical Corp. | JXG |
| Jan 27, 2003 | K024040 | ACCURA ELITE SHUNT SYSTEM Phoenix Biomedical Corp. | JXG |
| Aug 23, 2002 | K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Integra Neurosciences | JXG |
| Aug 6, 2002 | K021644 | PERF (OMMAYA STYLE) RESERVOIRS Phoenix Biomedical Corp. | JXG |
| Jul 29, 2002 | K021653 | CODMAN BACTISEAL EVD CATHETER SET Codman & Shurtleff, Inc. | JXG |
| Jul 1, 2002 | K021196 | NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 Neuron Therapeutics, Inc. | JXG |
| Mar 28, 2002 | K020667 | CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. | JXG |
| Mar 27, 2002 | K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 Sophysa SA | JXG |
| Mar 1, 2002 | K011030 | AESCULAP -MIETHKE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Feb 11, 2002 | K012052 | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 Medtronic PS Medical | JXG |
| Dec 20, 2000 | K003564 | HAKIM PROGRAMMER AND TRANSMITTER Codman & Shurtleff, Inc. | JXG |
| Dec 12, 2000 | K002970 | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 Medical Designs, LLC | JXG |
| Nov 9, 2000 | K002476 | LUMBOPERITONEAL SHUNT SYSTEM Phoenix Biomedical Corp. | JXG |
| Sep 21, 2000 | K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE Sophysa SA | JXG |
| Sep 12, 2000 | K991502 | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 Medtronic PS Medical | JXG |
| Aug 4, 2000 | K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Radionics, Inc. | JXG |
| May 10, 2000 | K000514 | RUMBAR DRAINAGE SYSTEM Phoenix Biomedical Corp. | JXG |
| Apr 7, 2000 | K992173 | SIPHONGUARD CSF CONTROL DEVICE Johnson & Johnson Professionals, Inc. | JXG |
| Mar 20, 2000 | K000057 | RADIONICS LUMBOPERITONEAL SHUNT Radionics, Inc. | JXG |
| Sep 23, 1999 | K990660 | NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX Nmt Neurosciences Implants S.A. | JXG |
| Sep 8, 1999 | K992379 | RADIONICS XDC EXTERNAL VENTRICULAR CATHETER Radionics, Inc. | JXG |
| May 26, 1999 | K981246 | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) Integra Neurocare, LLC | JXG |
| May 19, 1999 | K991429 | DIAMOND II VALVE Phoenix Biomedical Corp. | JXG |
| Apr 19, 1999 | K980903 | RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT Radionics, Inc. | JXG |
| Apr 1, 1999 | K990256 | CRX WORLD SHUNT Phoenix Biomedical Corp. | JXG |
| Mar 15, 1999 | K984583 | THE BIOPLATE SHUNT CONNECTOR Biomedics | JXG |
| Feb 4, 1999 | K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Medtronic PS Medical | JXG |
| Dec 8, 1998 | K974096 | CRX DIAMOND VALVE Phoenix Biomedical Corp. | JXG |
| Jul 17, 1998 | K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| Jul 1, 1998 | K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| Jun 16, 1998 | K981046 | MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 Medtronic PS Medical | JXG |
| Mar 18, 1998 | K974726 | SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER Elekta Implants, SA | JXG |
| Mar 10, 1998 | K974708 | GEMINI STANDARD AND MINI VALVES Neurocare Group | JXG |
| Feb 6, 1998 | K971799 | PRECISION FLOW OSV II Elekta Implants, SA | JXG |
| Dec 29, 1997 | K973774 | CODMAN HAKIM MICRO PRECISION VALVE Johnson & Johnson Professionals, Inc. | JXG |
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