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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K212817
Device Name Merit Siege Vascular Plug
Applicant
Merit Medical System, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Mark Mullaney
Correspondent
Merit Medical System, Inc.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact Siobhan King
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/03/2021
Decision Date 12/15/2021
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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