Cleared Traditional

Liberant Thrombectomy System

K250787 · Medtronic, Ireland · Cardiovascular

Jun 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K250787 is an FDA 510(k) clearance for the Liberant Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Medtronic, Ireland (Galway H91 Vy19, IE). The FDA issued a Cleared decision on June 11, 2025, 89 days after receiving the submission on March 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250787 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	June 11, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.