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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 K211898
Device Name ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto-Shi,  JP 489-0071
Applicant Contact Tomoya Eguchi
Correspondent
Asahi Intecc USA, Inc.
3002 Dow Ave.
Suite 212
Tustin,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/21/2021
Decision Date 12/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT02379923
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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