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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K242229
Device Name Micro Ace Gold Advanced Micro Access System
Applicant
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Niloufar Samimi
Correspondent
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Niloufar Samimi
Regulation Number870.1310
Classification Product Code
DRE  
Date Received07/30/2024
Decision Date 01/15/2025
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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