TriMemo SEMIRIGID ANNULOPLASTY RING— 510(k) K260498

Name: FDA 510(k) clearance K260498
Creator: U.S. Food and Drug Administration
Published: 2026-04-14

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.. Device class: 2.

Summary

Corcym's TriMemo SEMIRIGID ANNULOPLASTY RING is filed under product code KRH (Ring, Annuloplasty).

Class II, 21 CFR 870.3800. Cardiovascular is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).

Corcym filed from Saluggia, Italy. The decision came 60 calendar days after FDA received it (February 13 to April 14, 2026).

Clearance details

Applicant: Corcym S.r.l.
Product code: Product code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
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 ↗

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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.