Sizer, Heart-Valve, Prosthesis
FDA product code DTI · Class I (low risk) · 21 CFR 870.3945 · Cardiovascular
7510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | Carbomedics, Inc. | 11/29/1995SE |
| K934951 | Valve SizerDTI · Traditional | Carbomedics, Inc. | 12/10/1993SE |
| K881279 | Edwards-Duromedics Bileaflet Valve Sizer SetDTI · Traditional | Baxter Healthcare Corp | 05/18/1988SE |
| K853313 | Duromedics Cardiac Valve Sizer SetDTI · Traditional | Hemex Scientific, Inc. | 11/01/1985SE |
| K852612 | Metronic Model F7700 Heart Valve SizersDTI · Traditional | Medtronic Vascular | 09/23/1985SE |
| K820887 | Mitral Valve Orifice SizerDTI · Traditional | Celtech | 07/08/1982SE |
| K801885 | Hancock * ObturatorsDTI · Traditional | Hancock Laboratories, Inc. | 09/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1450-2020 Class II | Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral…Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The… | Medtronic CoreValve LLC | 01/14/2020Open, Classified |
| Z-1449-2020 Class II | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a…Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The… | Medtronic CoreValve LLC | 01/14/2020Open, Classified |