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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 K160659
Device Name ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
Applicant
Asahi Intecc Co., Ltd.
2055 Red Hill Ave., Suite 210
Santa Ana,  CA  92705
Applicant Contact CARROLL COUNCILMAN
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact CANDACE CEDERMAN
Regulation Number870.1330
Classification Product Code
MOF  
Date Received03/08/2016
Decision Date 04/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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