Aortic Annuloplasty Ring
FDA product code PST · Class II (moderate risk) · 21 CFR 870.3800 · Cardiovascular
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
2510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…PST · Traditional | Biostable Science & Engineering, Inc. | 08/10/2017SE |
| K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm…PST · Traditional | Biostable Science & Engineering, Inc. | 03/21/2017SE |