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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K230418
Device Name Mighty Wire Guide Wire
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 West
Galway,  IE
Correspondent Contact James Kenny
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/16/2023
Decision Date 10/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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