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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K251668
Device Name SurfRider 13 Microcatheter
Applicant
Kaneka Americas Holding, Inc.
7979 Gateway Blvd.
Suite 220
Newark,  CA  94560
Applicant Contact Takuji Nishide
Correspondent
Mededge
635 Hibiscus St.
#2101
West Palm,  FL  33401
Correspondent Contact Darci Diage
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
KRA  
Date Received05/30/2025
Decision Date 01/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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