Cleared Special

Trevo NXT ProVue Retriever

K200117 · Stryker · Neurology

Feb 2020

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K200117 is an FDA 510(k) clearance for the Trevo NXT ProVue Retriever, a Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (Class II — Special Controls, product code POL), submitted by Stryker (Freemont, US). The FDA issued a Cleared decision on February 7, 2020, 17 days after receiving the submission on January 21, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K200117 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2020
Decision Date	February 07, 2020
Days to Decision	17 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	POL — Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5600
Definition	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.