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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 K251240
Device Name Branchor X Balloon Guide Catheter
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto,  JP 489-0071
Applicant Contact Fujimura Katsuhiko
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Ave.
Suite 212
Tustin,  CA  92780
Correspondent Contact Esther Kim
Regulation Number870.1250
Classification Product Code
QJP  
Date Received04/22/2025
Decision Date 06/20/2025
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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