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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 K252011
Device Name CHIKAI Nexus petit
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto-Shi,  JP 489-0071
Applicant Contact Katsuhiko Fujimura
Correspondent
Asahi Intecc USA, Inc.
22 Executive Park
Suite 110
Irvine,  CA  92614
Correspondent Contact Ariel Barret
Regulation Number870.1330
Classification Product Code
MOF  
Date Received06/27/2025
Decision Date 02/02/2026
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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