Carpentier-Edwards Physio Annuloplasty Ring (4450)— 510(k) K251688

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K251688 for Carpentier-Edwards Physio Annuloplasty Ring (4450), Substantially Equivalent on 2025-09-17. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2025-06-02
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.