Clearance Summary
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring received FDA 510(k) clearance under submission number K230318, sponsored by Corcym S.r.l.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-04-07.
- Submission: K230318
- Applicant / Sponsor: Corcym S.r.l.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 2023-04-07
Classification & Regulation
This clearance is catalogued under FDA product code KRH and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.