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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K213845
Device Name HeRO Graft
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Susan Christensen
Correspondent
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Susan Christensen
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Codes
LJS   MSD  
Date Received12/09/2021
Decision Date 08/15/2022
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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