De Novo DEN150049

Device
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
Contact
jim leathley
De Novo number
DEN150049
Product code
POL
Regulation
882.5600
Classification name
neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
Decision
granted (DENG)
Decision date
2016-09-02
Date received
2015-10-26
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
POL
Device name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Medical specialty
Neurology
Device class
2
Regulation
882.5600
Implant
N
Life sustain/support
N