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510(k) K200117

Trevo NXT ProVue Retriever by Stryker — Product Code POL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2020
Date Received
January 21, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class
Class II
Regulation Number
882.5600
Review Panel
NE
Submission Type

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

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Other clearances for product code POL

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