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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
510(k) Number K241158
Device Name ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto-Shi,  JP 489-0071
Applicant Contact Fujimura Katsuhiko
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Ave.
Suite 212
Tustin,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/26/2024
Decision Date 06/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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