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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 K193576
Device Name Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Helen Chow
Correspondent
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Jennifer L Correa
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received12/23/2019
Decision Date 11/20/2020
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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