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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K173548
Device Name Merit Pursue Microcatheter
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 Number870.1250
Classification Product Code
DQY  
Date Received11/16/2017
Decision Date 03/30/2018
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
Recalls CDRH Recalls
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