MEMO 4D Curve™ Semirigid mitral annuloplasty ring

FDA 510(k) K261707 · Corcym S.r.l.

Substantially Equivalent

510(k) numberK261707

Submission

Device name
MEMO 4D Curve™ Semirigid mitral annuloplasty ring
Applicant
Corcym S.r.l.
Saluggia, IT
Received
May 22, 2026
Decision date
June 18, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRH – Ring, Annuloplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3800
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code KRH

510(k)DeviceApplicantDecision
K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated Corcym S.r.l.04/14/2026SE
K253232Seguin Annuloplasty RingKRH · Special Abbott Medical10/29/2025SE
K251982Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated Edwards Lifesciences, LLC09/23/2025SE
K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated Edwards Lifesciences, LLC09/17/2025SE
K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.07/25/2025SE
K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.04/09/2024SE
K230679WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional Genesee Biomedical, Inc.05/26/2023SE
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional Corcym S.r.l.04/07/2023SE
K202253TruForm Sievers Annuloplasty RingKRH · Traditional Genesee Biomedical, Inc.10/06/2020SE
K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm…KRH · Special Medtronic, Inc.07/01/2020SE

More from Medtronic, Inc.

510(k)DeviceDecision
K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated 04/14/2026SE
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional 04/07/2023SE

Questions and answers

When was MEMO 4D Curve™ Semirigid mitral annuloplasty ring cleared by the FDA?

MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 27 days after the submission was received.

What is the product code of K261707?

The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.