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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K260498
Device Name TriMemo™ SEMIRIGID ANNULOPLASTY RING
Applicant
Corcym S.r.l.
Via Crescentino Sn
Saluggia,  IT 13040
Applicant Contact Silvia Contadini
Correspondent
Corcym S.r.l.
Via Crescentino Sn
Saluggia,  IT 13040
Correspondent Contact Adelina Chiaravalloti
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/13/2026
Decision Date 04/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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