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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 K261640
Device Name Merit MAK Nitinol/Gold-Tungsten Guide Wire
Applicant
Merit Medical Ireland , Ltd.
Parkmore Business Park W.
Galway,  IE
Applicant Contact Siobhan King
Correspondent
Merit Medical Ireland , Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact Siobhan King
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/18/2026
Decision Date 07/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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