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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 K141751
Device Name ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
Applicant
Asahi Intecc Co., Ltd.
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Applicant Contact SEMIH OKTAY
Correspondent
Asahi Intecc Co., Ltd.
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact SEMIH OKTAY
Regulation Number870.1330
Classification Product Code
MOF  
Date Received06/30/2014
Decision Date 01/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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