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 3, 1990 | K900676 | CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 21, 1989 | K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR Pudenz-Schulte Medical Research Corp. | JXG |
| Aug 21, 1989 | K892215 | UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT Codman & Shurtleff, Inc. | JXG |
| Aug 7, 1989 | K894072 | THE PUDENZ IN LINE VALVE Baxter Healthcare Corp | JXG |
| Jun 23, 1989 | K891456 | HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM Baxter Healthcare Corp | JXG |
| Dec 22, 1988 | K884036 | PMT MODEL 1110-5 PMT PERITONEAL CATHETER Pmt Corp. | JXG |
| Sep 9, 1988 | K881616 | PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 Progress Mankind Technology | JXG |
| Aug 24, 1988 | K883114 | SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1 Pmt Corp. | JXG |
| Jul 14, 1988 | K875287 | H-H FLUSHING RESERVOIR Holter-Hausner Intl. | JXG |
| May 31, 1988 | K875205 | TRI-FLOW CATHETER Neurodynamics, Inc. | JXG |
| Jan 19, 1988 | K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG Holter-Hausner Intl. | JXG |
| Sep 18, 1987 | K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL Pudenz-Schulte Medical Research Corp. | JXG |
| Jun 12, 1987 | K871685 | HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS American V. Mueller | JXG |
| May 22, 1987 | K871752 | CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. | JXG |
| May 1, 1987 | K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS Holter-Hausner Intl. | JXG |
| Dec 29, 1986 | K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM American V. Mueller | JXG |
| Dec 3, 1986 | K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE Pudenz-Schulte Medical Research Corp. | JXG |
| Aug 12, 1986 | K862303 | BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. Pudenz-Schulte Medical Research Corp. | JXG |
| Aug 12, 1986 | K861961 | CAMINO CSF DRAINAGE SYSTEM MODEL 040 Camino Laboratories, Inc. | JXG |
| Aug 1, 1986 | K862513 | EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS Cordis Corp. | JXG |
| Jun 19, 1986 | K861377 | STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES Cordis Corp. | JXG |
| Jan 10, 1986 | K855058 | EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID Cordis Corp. | JXG |
| Nov 27, 1985 | K854474 | EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE Cordis Corp. | JXG |
| Nov 27, 1985 | K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT American V. Mueller | JXG |
| Sep 18, 1985 | K853371 | H-H ATRIAL CATHETERS & PERITONEAL CATHETERS Holter-Hausner Intl. | JXG |
| Sep 16, 1985 | K853215 | ACCU-FLO PRESSURE VALVE Codman & Shurtleff, Inc. | JXG |
| Sep 11, 1985 | K853369 | H-H FIXATION & JOINING CONNECTORS Holter-Hausner Intl. | JXG |
| Sep 11, 1985 | K853366 | H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT Holter-Hausner Intl. | JXG |
| Sep 5, 1985 | K853365 | H-H FIFTH VENTRICLE Holter-Hausner Intl. | JXG |
| Sep 5, 1985 | K853364 | H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. | JXG |
| Sep 3, 1985 | K853363 | H-H CRUCIFORM-SLIT VALVE Holter-Hausner Intl. | JXG |
| Sep 3, 1985 | K853362 | H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER Holter-Hausner Intl. | JXG |
| Aug 28, 1985 | K853361 | H-H VENTRICULAR CATHETERS & RESERVOIRS Holter-Hausner Intl. | JXG |
| Sep 12, 1984 | K843132 | RADIONICS MINI & STANDARD SHUNT VALVE Radionics, Inc. | JXG |
| Apr 19, 1984 | K841442 | P-S MEDICAL CSF-FLOW CONTROL VALVE- P-S Medical | JXG |
| Apr 3, 1984 | K834593 | ONE-PIECE SHUNT American Heyer Schulte | JXG |
| Aug 12, 1983 | K831396 | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT Pudenz-Schulte Medical Research Corp. | JXG |
| Jun 24, 1983 | K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR Pudenz-Schulte Medical Research Corp. | JXG |
| Apr 8, 1983 | K830894 | H-H IN-LINE VALVED CATHETER 2 TYPES Holter-Hausner Intl. | JXG |
| Mar 9, 1983 | K823503 | P-S CSF-VENTRICULAR CATHETER, FLANGED Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 16, 1982 | K823509 | P-S MED. LUMBO PERITONEAL & VENTRICULO- Pudenz-Schulte Medical Research Corp. | JXG |
| Mar 1, 1982 | K820312 | H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. | JXG |
| Feb 24, 1982 | K820311 | H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. | JXG |
| Feb 18, 1982 | K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. American Heyer Schulte | JXG |
| Jun 26, 1981 | K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM American Heyer Schulte | JXG |
| Jan 22, 1981 | K803257 | CSG-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp. | JXG |
| Dec 18, 1980 | K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE American Heyer Schulte | JXG |
| Jan 31, 1980 | K800168 | H-H FIFTH VENTRICLE Holter-Hausner Intl. | JXG |
| Jan 16, 1980 | K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES Pudenz-Schulte Medical Research Corp. | JXG |
| Jan 16, 1980 | K792005 | CSF-CARDIAC/PERITONEAL CATHETER Pudenz-Schulte Medical Research Corp. | JXG |
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