Cleared Traditional

Helo Thrombectomy System

K252956 · Endovascular Engineering, Inc. · Cardiovascular

Dec 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K252956 is an FDA 510(k) clearance for the Helo Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Endovascular Engineering, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 18, 2025, 93 days after receiving the submission on September 16, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K252956 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2025
Decision Date	December 18, 2025
Days to Decision	93 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.