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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K202850
Device Name Concerto Versa, Detachable Coil
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact Rita De Rama
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact Rita De Rama
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/28/2020
Decision Date 02/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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