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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 K251385
Device Name InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
Applicant
Merit Medical Ireland, Ltd.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Applicant Contact Shane Costello
Correspondent
Merit Medical Ireland, Ltd.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Correspondent Contact Shane Costello
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/05/2025
Decision Date 01/21/2026
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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