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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 K201449
Device Name SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
Applicant
Medtronic, Inc.
1851 E. Deere Ave.
Santa Ana,  CA  92705
Applicant Contact Lisa Corbin
Correspondent
Medtronic, Inc.
1851 E. Deere Ave.
Santa Ana,  CA  92705
Correspondent Contact Lisa Corbin
Regulation Number870.3800
Classification Product Code
KRH  
Date Received06/01/2020
Decision Date 07/01/2020
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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