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 Number | 882.5600
|
Classification Product Code |
|
Date Received | 10/26/2015 |
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
|
|
|