K251982 is an FDA 510(k) clearance for the Edwards MC3 Tricuspid annuloplasty ring (4900). This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on September 23, 2025, 88 days after receiving the submission on June 27, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K251982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | September 23, 2025 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRH — Ring, Annuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3800 |