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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K210638
Device Name i-ED COIL System
Applicant
Kaneka Medical America, LLC
623 Fifth Ave.
New York,  NY  10022
Applicant Contact Audra Bogucki
Correspondent
KANEKA Corporation
1-12-32, Akasaka
Minato-Ku,  JP 107-6028
Correspondent Contact Takeaki Miyata
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received03/03/2021
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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