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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 K254137
Device Name InQwire Amplatz Guide Wire
Applicant
Merit Medical Ireland, Ltd.
Parkmore Business Park W.
Galway,  IE
Applicant Contact Brian Coughlan
Correspondent
Merit Medical Ireland, Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact Brian Coughlan
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/22/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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