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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
De Novo Number DEN150049
Device Name Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
Requester
concentric medical, inc.
301 east evelyn avenue
mountain view,  CA  94041
Contact jim leathley
Regulation Number882.5600
Classification Product Code
POL  
Date Received10/26/2015
Decision Date 09/02/2016
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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