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 |
|---|---|---|---|
| Aug 3, 1979 | K791076 | H-H SLOTTED VENTRICULAR CATHETER Holter-Hausner Intl. | JXG |
| Aug 3, 1979 | K791075 | H-H SLOTTED CATHETER-RESERVOIR Holter-Hausner Intl. | JXG |
| May 11, 1979 | K790849 | H-H FIXATION AND JOINING CONNECTORS Holter-Hausner Intl. | JXG |
| Jan 26, 1979 | K790126 | VALVE, H-H CRUCIFORM SLIT Holter-Hausner Intl. | JXG |
| Jan 15, 1979 | K782105 | CATHETERS, H-H VENTRICULAR Holter-Hausner Intl. | JXG |
| Nov 14, 1978 | K781768 | CATHETERS, H-H ATRIAL AND PERITONEAL Holter-Hausner Intl. | JXG |
| Nov 1, 1976 | K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH Heyer Schulte Corp. | JXG |
| Nov 1, 1976 | K760784 | MISHLER 2 CHAMB FLUSHING VALVE,STAND Heyer Schulte Corp. | JXG |
| Aug 30, 1976 | K760502 | VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. Joe W. Utt | JXG |
| Aug 30, 1976 | K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING Heyer Schulte Corp. | JXG |
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