PST
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aortic Annuloplasty Ring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Medical specialty
- Cardiovascular
- Flags
- Implant · Life-sustaining
- FDA definition
- To correct annular dilatation and/or maintain annular geometry of the aortic valve.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (K171431) | Biostable Science & Engineering, Inc. | 2017-08-10 | + Add |
| HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (K163608) | Biostable Science & Engineering, Inc. | 2017-03-21 | + Add |
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Every clearance here is in the API, with alerts when new ones post.