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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 K181807
Device Name Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
Applicant
Micro Therapeutics Inc., d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact Jennifer Correa
Correspondent
Micro Therapeutics Inc., d/b/a ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact Helen Chow
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received07/06/2018
Decision Date 03/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02586415
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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