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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 K253232
Device Name Seguin Annuloplasty Ring
Applicant
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Applicant Contact Bryan Soto
Correspondent
ABBOTT MEDICAL
177 County Rd. B E.
St. Paul,  MN  55117
Correspondent Contact Bryan Soto
Regulation Number870.3800
Classification Product Code
KRH  
Subsequent Product Code
DTI  
Date Received09/29/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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