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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 K240261
Device Name Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Applicant
Merit Medical Systems, Inc.
1600 Merit Pkwy. Bldg. 87
South Jordan,  UT  84095
Applicant Contact James Kenny
Correspondent
Merit Medical Ireland, Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact James Kenny
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/31/2024
Decision Date 05/02/2024
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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