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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 K112979
Device Name ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
Applicant
Asahi Intecc Co., Ltd.
2500 Red Hill Ave.
Suite 210
Santa Ana,  CA  92705
Applicant Contact YOSHI TERAI
Correspondent
Asahi Intecc Co., Ltd.
2500 Red Hill Ave.
Suite 210
Santa Ana,  CA  92705
Correspondent Contact YOSHI TERAI
Regulation Number870.1330
Classification Product Code
MOF  
Date Received10/06/2011
Decision Date 12/01/2011
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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