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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K243733
Device Name SION blue PLUS
Applicant
ASAHI INTECC CO., LTD.
3-100 Akatsuki-cho
Seto,  JP 489-0071
Applicant Contact Katsuhiko Fujimura
Correspondent
ASAHI INTECC USA, INC.
3002 Dow Avenue
Suite 212
Tustin,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/04/2024
Decision Date 04/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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