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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 K200871
Device Name Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Applicant
Control Medical Technology
2757 S. 300 W. Suite F (Zien)
Salt Lake City,  UT  84115
Applicant Contact Shawn Fojtik
Correspondent
Control Medical Technology
2757 S. 300 W. Suite F (Zien)
Salt Lake City,  UT  84115
Correspondent Contact Shawn Fojtik
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received04/01/2020
Decision Date 05/04/2020
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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