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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 K171613
Device Name ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
Applicant
Asahi Intecc Co., Ltd.
1703 Wakita-Cho, Moriyama-Ku
Hagoya-Shi,  JP 463-0024
Applicant Contact Yasuyuki Kawahara
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 Received06/01/2017
Decision Date 07/01/2017
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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