K251982
- 510(k) number
- K251982
- Device name
- Edwards MC3 Tricuspid annuloplasty ring (4900)
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- KRH — Ring, Annuloplasty
- Decision date
- 2025-09-23
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251982.pdf
Official FDA record: K251982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.