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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
510(k) Number K203358
Device Name Solitaire X Revascularization Device
Applicant
Micro Therapeutics, Inc d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Kevin Kong
Correspondent
Micro Therapeutics, Inc d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Kevin Kong
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received11/16/2020
Decision Date 03/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02239640
Reviewed by Third Party No
Combination Product No
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