Cleared Traditional

Solitaire X Revascularization Device

K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology

Mar 2021

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K203358 is an FDA 510(k) clearance for the Solitaire X Revascularization Device, a Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (Class II — Special Controls, product code POL), submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Lrvine, US). The FDA issued a Cleared decision on March 1, 2021, 105 days after receiving the submission on November 16, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K203358 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2020
Decision Date	March 01, 2021
Days to Decision	105 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.