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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K230636
Device Name Maestro Microcatheter
Applicant
Merit Medical System, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Garry Courtney
Correspondent
Merit Medical System, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Garry Courtney
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
DXT  
Date Received03/07/2023
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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