TriMemo SEMIRIGID ANNULOPLASTY RING— 510(k) K260498

Substantially Equivalent

Corcym S.r.l.

FDA 510(k) clearance K260498 for TriMemo SEMIRIGID ANNULOPLASTY RING, Substantially Equivalent on 2026-04-14. Applicant: Corcym S.r.l..

Clearance details

Applicant: Corcym S.r.l.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2026-02-13
Decision date: 2026-04-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Saluggia, IT

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.