Panels › Cardiovascular › Product code DTI · Class 1
Sizer, Heart-Valve, Prosthesis
Regulation 870.3945
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in DTI
| Company | 510(k)s | Recalls |
|---|---|---|
| Carbomedics, Inc. | 2 | 0 |
| Medtronic CoreValve LLC | 0 | 2 |
| Baxter Healthcare Corp | 1 | 0 |
| Celtech | 1 | 0 |
| Hancock Laboratories, Inc. | 1 | 0 |
| Hemex Scientific, Inc. | 1 | 0 |
| Medtronic Vascular | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 1995 | K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER Carbomedics, Inc. | DTI |
| Dec 10, 1993 | K934951 | VALVE SIZER Carbomedics, Inc. | DTI |
| May 18, 1988 | K881279 | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET Baxter Healthcare Corp | DTI |
| Nov 1, 1985 | K853313 | DUROMEDICS CARDIAC VALVE SIZER SET Hemex Scientific, Inc. | DTI |
| Sep 23, 1985 | K852612 | METRONIC MODEL F7700 HEART VALVE SIZERS Medtronic Vascular | DTI |
| Jul 8, 1982 | K820887 | MITRAL VALVE ORIFICE SIZER Celtech | DTI |
| Sep 9, 1980 | K801885 | HANCOCK * OBTURATORS Hancock Laboratories, Inc. | DTI |
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