PST · Aortic Annuloplasty Ring
Cardiovascular · 21 CFR 870.3800 · Class 2
Overview
| Product Code | PST |
|---|---|
| Device Name | Aortic Annuloplasty Ring |
| Regulation | 21 CFR 870.3800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Aug 10, 2017 | SESE |
| 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. | Mar 21, 2017 | SESE |
Top Applicants
- Biostable Science & Engineering, Inc. — 2 clearances
