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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 K230318
Device Name Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
Applicant
Corcym S.r.l.
Via Crescentino S.N
Saluggia,  IT 13040
Applicant Contact Silvia Contadini
Correspondent
Corcym S.r.l.
Via Crescentino S.N
Saluggia,  IT 13040
Correspondent Contact Silvia Contadini
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/06/2023
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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