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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 K251596
Device Name Lunderquist Extra Stiff Wire Guide
Applicant
William Cook Europe Aps
Sandet 6
Bjaeverskov,  DK 4632
Applicant Contact Mie Dyrholm
Correspondent
William Cook Europe Aps
Sandet 6
Bjaeverskov,  DK 4632
Correspondent Contact Anette Hulstrom
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/27/2025
Decision Date 11/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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