Cleared Traditional

Trevo NXT ProVue Retriever

K223305 · Stryker Neurovascular · Neurology

Mar 2023

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K223305 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 Neurovascular (Freemont, US). The FDA issued a Cleared decision on March 29, 2023, 153 days after receiving the submission on October 27, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K223305 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2022
Decision Date	March 29, 2023
Days to Decision	153 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.