FDA Product Code
FDA Product Code PST — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3800
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. | 2017-08-10 | Traditional | PDF ↗ |
| K163608 | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. | 2017-03-21 | Traditional | PDF ↗ |
Product code PST · Class II · Cardiovascular. Data: openFDA.