K251688
- 510(k) number
- K251688
- Device name
- Carpentier-Edwards Physio Annuloplasty Ring (4450)
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- KRH — Ring, Annuloplasty
- Decision date
- 2025-09-17
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K251688.pdf
Official FDA record: K251688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.