510(k) K261707

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

K261707 is an FDA 510(k) premarket notification submitted by Corcym S.r.l. for the device "MEMO 4D Curve™ Semirigid mitral annuloplasty ring". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Corcym S.r.l. has at least 2 other 510(k) clearances on record.

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