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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 K241521
Device Name Prelude Small O.D. Introducer 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 W.
Galway H91 Vy19,  IE
Correspondent Contact James Kenny
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/29/2024
Decision Date 12/10/2024
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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