PST — Aortic Annuloplasty Ring Class II
FDA product code PST covers "Aortic Annuloplasty Ring", a Class II medical device regulated under 21 CFR 870.3800. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PST
- Device Class
- Class II
- Regulation Number
- 870.3800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
To correct annular dilatation and/or maintain annular geometry of the aortic valve.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171431 | biostable science and engineering | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device | August 10, 2017 |
| K163608 | biostable science and engineering | HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device | March 21, 2017 |