MEMO 4D Curve Semirigid mitral annuloplasty ring— 510(k) K261707
Substantially EquivalentCorcym S.r.l.
FDA 510(k) clearance K261707 for MEMO 4D Curve Semirigid mitral annuloplasty ring, Substantially Equivalent on 2026-06-18. Applicant: Corcym S.r.l.. Device class: 2.
Summary
Corcym's MEMO 4D Curve Semirigid mitral annuloplasty ring is filed under KRH, annuloplasty rings. The semirigid and mitral descriptions come from the device name; the record gives no ring sizes.
Class II, 21 CFR 870.3800. Cardiovascular is both the classification panel and the review panel, and the submission was a Special 510(k).
Corcym filed from Saluggia, Italy. The decision came 27 calendar days after FDA received it (May 22 to June 18, 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saluggia, IT
Recent devices under product code KRH
view allMore clearances from Corcym S.r.l.
view allAdverse events under product code KRH
product code KRH- Death
- 45
- Injury
- 2,235
- Total
- 2,280
Source: openFDA MAUDE database, through . 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.