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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K213166
Device Name Thrombuster II Aspiration Catheter
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 Number870.5150
Classification Product Code
QEZ  
Date Received09/28/2021
Decision Date 10/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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