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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 K254178
Device Name SAYA 86 Radial Access Guide Catheter
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto,  JP 489-0071
Applicant Contact Katsuhiko Fujimura
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Ave.
Suite 212
Tustin,  CA  92780
Correspondent Contact Ariel Barrett
Regulation Number870.1250
Classification Product Code
QJP  
Date Received12/23/2025
Decision Date 05/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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