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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K253168
Device Name 0.014” Willow Guidewire
Applicant
Arbor Endovascular, LLC
2345 Bering Dr.
San Jose,  CA  95131
Applicant Contact Kim Otto
Correspondent
Fabrica Consulting, LLC
2345 Bering Dr.
San Jose,  CA  95131
Correspondent Contact Kathy Tansey
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received09/26/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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