Cleared Special

Aventus Thrombectomy System (IM-2100)

K250668 · Inquis Medical · Cardiovascular

Mar 2025

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K250668 is an FDA 510(k) clearance for the Aventus Thrombectomy System (IM-2100), 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 March 25, 2025, 20 days after receiving the submission on March 5, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250668 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2025
Decision Date	March 25, 2025
Days to Decision	20 days
Submission Type	Special
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.