Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring— 510(k) K230318

Name: FDA 510(k) clearance K230318
Creator: U.S. Food and Drug Administration
Published: 2023-04-07

Substantially Equivalent

Corcym S.r.l.

FDA 510(k) clearance K230318 for Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring, Substantially Equivalent on 2023-04-07. Applicant: Corcym S.r.l.. Device class: 2.

Clearance details

Applicant: Corcym S.r.l.
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2023-02-06
Decision date: 2023-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saluggia, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRH

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K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring2026-06-18
K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING2026-04-14
K253232 — Seguin Annuloplasty Ring2025-10-29
K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17

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.