Cleared Traditional

Trevo XP ProVue Retriever and Trevo NXT? ProVue Retriever

K203219 · Stryker Neurovascular · Neurology

Dec 2020

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K203219 is an FDA 510(k) clearance for the Trevo XP ProVue Retriever and Trevo NXT? ProVue Retriever, a Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (Class II — Special Controls, product code POL), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on December 29, 2020, 57 days after receiving the submission on November 2, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K203219 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2020
Decision Date	December 29, 2020
Days to Decision	57 days
Submission Type	Traditional
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.