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 |
|---|---|---|---|
| Dec 16, 1997 | K973525 | MAURICE WORLDWIDE SHUNT SYSTEM Integra Neurocare, LLC | JXG |
| Nov 3, 1997 | K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS Integra Neurocare, LLC | JXG |
| Jul 31, 1997 | K971617 | ENDOSCOPIC VENTRICULAR CATHETER Integra Neurocare, LLC | JXG |
| Jul 24, 1997 | K971511 | RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. | JXG |
| Jun 25, 1997 | K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT Johnson & Johnson Professionals, Inc. | JXG |
| Jun 13, 1997 | K970983 | PERITONEAL/CARDIAC CATHETER Integra Neurocare, LLC | JXG |
| Jun 4, 1997 | K970578 | RADIONICS BURR HOLE VALVE Radionics, Inc. | JXG |
| May 19, 1997 | K970658 | LUMBAR DRAINAGE ACCESSORY KIT Integra Neurocare, LLC | JXG |
| Jan 31, 1997 | K964386 | RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. | JXG |
| Jan 31, 1997 | K964371 | SHUNT TAP WITH ICP MONITORING ACCESS PORT Integra Neurocare, LLC | JXG |
| Dec 20, 1996 | K955265 | CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER Cordis Corp. | JXG |
| Dec 16, 1996 | K961859 | NOVUS STANDARD AND PEDIATRIC VALVES Integra Neurocare, LLC | JXG |
| Dec 12, 1996 | K963802 | SHUNT TAP Integra Neurocare, LLC | JXG |
| Oct 25, 1996 | K960159 | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) Cordis Corp. | JXG |
| Oct 23, 1996 | K962990 | RADIONICS SIPHON LIMITING DEVICE (SLD) Radionics, Inc. | JXG |
| Aug 29, 1996 | K962097 | VENTRICULAR CATHETER SET Cook, Inc. | JXG |
| Aug 27, 1996 | K960435 | PHOENIX CRX VALVE Phoenix Biomedical Corp. | JXG |
| Mar 25, 1996 | K955832 | CORDIS VENTRICULAR ANTECHAMBER (VA) Cordis Corp. | JXG |
| Jan 26, 1996 | K954285 | CONTOUR FLEX VALVES (REGULAR & SMALL) Radionics, Inc. | JXG |
| Oct 24, 1995 | K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) Johnson & Johnson Professionals, Inc. | JXG |
| Oct 19, 1995 | K944595 | CORDIS HORIZONTAL-VERICAL VALVE SYSTEM Cordis Corp. | JXG |
| Sep 18, 1995 | K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp. | JXG |
| Jul 28, 1995 | K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM Johnson & Johnson Professionals, Inc. | JXG |
| Mar 30, 1995 | K932769 | CAMINO VENTRICULAR DRAINAGE SYSTEM Camino Laboratories, Inc. | JXG |
| Nov 7, 1994 | K935560 | PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) Pmt Corp. | JXG |
| Jul 20, 1994 | K932429 | CORDIS GRAVITY COMPENSATING ACCESSORY Cordis Corp. | JXG |
| Apr 28, 1994 | K934545 | PS MEDICAL DELTA BURR HOLE VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Mar 2, 1994 | K925810 | CORDIS POLYPROPYLENE BURR HOLE RESERVOIR Cordis Corp. | JXG |
| Jul 21, 1993 | K931989 | VENTRI-CATH Gesco Intl., Inc. | JXG |
| Apr 15, 1993 | K930222 | CAMINO VENTRICULAR ACCESS DEVICE Camino Laboratories, Inc. | JXG |
| Mar 30, 1993 | K913412 | PS MEDICAL CSF-ACCESS DEVICE Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 10, 1992 | K924600 | INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS Cordis Corp. | JXG |
| Oct 30, 1992 | K921936 | CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR Cordis Corp. | JXG |
| Aug 26, 1992 | K922941 | CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA Clinical Neuro Systems, LLC | JXG |
| Aug 26, 1992 | K922936 | CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE Clinical Neuro Systems, LLC | JXG |
| Mar 16, 1992 | K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY Clinical Neuro Systems, LLC | JXG |
| Mar 9, 1992 | K914995 | CORDIS STRAIGHT VENTRICULAR CATHETER Cordis Corp. | JXG |
| Feb 19, 1992 | K913842 | CORDIS RIGHT-ANGLE CATHETER GUIDE Cordis Corp. | JXG |
| Dec 12, 1991 | K913636 | ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING Cordis Corp. | JXG |
| Sep 16, 1991 | K911433 | RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE Cordis Corp. | JXG |
| Sep 10, 1991 | K905860 | HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION Baxter Healthcare Corp | JXG |
| Aug 16, 1991 | K910938 | CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) Codman & Shurtleff, Inc. | JXG |
| Jul 24, 1991 | K904883 | OPTYX Baxter Healthcare Corp | JXG |
| Jun 28, 1991 | K911410 | PS MEDICAL BUTTON VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Apr 24, 1991 | K910853 | GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET Cordis Corp. | JXG |
| Dec 28, 1990 | K903844 | OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING Cordis Corp. | JXG |
| Oct 9, 1990 | K904120 | ACCU-FLO* UNITIZED SHUNT Codman & Shurtleff, Inc. | JXG |
| Aug 8, 1990 | K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Jul 19, 1990 | K902257 | CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) Codman & Shurtleff, Inc. | JXG |
| Apr 10, 1990 | K895524 | HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. Theramed, Inc. | JXG |
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