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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 K181060
Device Name Solitaire 2 and Solitaire Platinum Revascularization Device
Applicant
Medtronic Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Applicant Contact Amnon Talmor
Correspondent
Medtronic Neurovascular
9775 Toledo Way
Irvine,  CA  92618
Correspondent Contact Amnon Talmor
Regulation Number882.5600
Classification Product Code
POL  
Subsequent Product Code
NRY  
Date Received04/23/2018
Decision Date 08/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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