FDA 510(k) Applications for Medical Device Product Code "PST"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K163608 | BioStable Science & Engineering Inc. | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm | 03/21/2017 |
| K171431 | BioStable Science & Engineering, Inc. | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | 08/10/2017 |
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