ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
Device Facts
| Record ID | K083683 |
|---|---|
| Device Name | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC |
| Applicant | Genesee Biomedical, Inc. |
| Product Code | KRH · Cardiovascular |
| Decision Date | Feb 25, 2009 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.3800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
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.”
