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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 K253746
Device Name Enroute 0.014'' Transcarotid Guidewire
Applicant
Lake Region Medical
Parkmore W. Business Park
Galway,  IE H91 CK22
Applicant Contact Amy Carter
Correspondent
Lake Region Medical
Parkmore W. Business Park
Galway,  IE H91 CK22
Correspondent Contact Amy Carter
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/25/2025
Decision Date 03/19/2026
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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