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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2020 | Medtronic CoreValve LLC Medtronic
Simulus 850
Semi Rigid Ring/Band Accessory Kit
Used to size a patient's mitral or tricuspid valve in cardiac procedures. Open, Classified |
DTI | None listed |
| Feb 14, 2020 | Medtronic CoreValve LLC Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures. Open, Classified |
DTI | None listed |
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