COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
Device Facts
| Record ID | K923367 |
|---|---|
| Device Name | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 |
| Applicant | Baxter Healthcare Corp |
| Product Code | KRH · Cardiovascular |
| Decision Date | Jan 6, 1993 |
| Decision | SESP |
| Submission Type | Traditional |
| 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.”
