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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
Model WAIN-CKI-10-200 & WAIN-CKI-10-300
Device Name ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
Original Applicant
ASAHI INTECC CO., LTD.
2500 red hill ave, suite 210
santa ana,  CA  92705
Original Contact yoshi terai
Regulation Number870.1330
Classification Product Code
MOF  
Date Received10/12/2011
Decision Date 12/01/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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