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510(k) K261707

MEMO 4D Curve™ Semirigid mitral annuloplasty ring by Corcym S.r.l. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
May 22, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

Other clearances by Corcym S.r.l.

  • K260498 — TriMemo™ SEMIRIGID ANNULOPLASTY RING (April 14, 2026)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)

Other clearances for product code KRH

  • K260498 — TriMemo™ SEMIRIGID ANNULOPLASTY RING (April 14, 2026)
  • K253232 — Seguin Annuloplasty Ring (October 29, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuFo (July 1, 2020)