Cleared Traditional

Aventus Thrombectomy System

K251189 · Inquis Medical · Cardiovascular

Jun 2025

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K251189 is an FDA 510(k) clearance for the Aventus Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on June 13, 2025, 57 days after receiving the submission on April 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K251189 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2025
Decision Date	June 13, 2025
Days to Decision	57 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.