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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 K190176
Device Name MINAMO
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto,  JP 489-0071
Applicant Contact Yasuyuki Kawahara
Correspondent
CardioMed Device Consultants, LLC
3168 Braverton St.
Suite 200
Edgewater,  MD  21037
Correspondent Contact Candace Cederman
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/01/2019
Decision Date 08/01/2019
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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