FDA product code PST: Aortic Annuloplasty Ring
PST is the FDA product code for aortic annuloplasty ring. It is a Class II device, regulated under 21 CFR 870.3800 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under PST. The average 510(k) review took 88 days (median 88).
Definition
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
Classification
| Field | Value |
|---|---|
| Device name | Aortic Annuloplasty Ring |
| Device class | Class II |
| Regulation | 21 CFR 870.3800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PST
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 88 |
Compare with all 510(k) review times · Search every PST clearance
Top PST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biostable Science & Engineering, Inc. | 2 | 2017-08-10 |
Most recent PST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2017-08-10 | 87 |
| 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 | 2017-03-21 | 90 |
Recalls for PST devices
openFDA lists no recalls for product code PST.
Frequently asked questions
What is FDA product code PST?
PST is the FDA product code for aortic annuloplasty ring. It is a Class II device, regulated under 21 CFR 870.3800 and reviewed by the Cardiovascular panel.
What device class is PST?
Class II, regulation 21 CFR 870.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code PST?
Across 2 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most PST clearances?
Biostable Science & Engineering, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PST
- Run a recall and safety report across every PST manufacturer
- Watch product code PST for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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