Cleared Traditional

Aventus Thrombectomy System

K253925 · Inquis Medical · Cardiovascular

Jan 2026

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K253925 is an FDA 510(k) clearance for the Aventus Thrombectomy System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on January 15, 2026, 38 days after receiving the submission on December 8, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K253925 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2025
Decision Date	January 15, 2026
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.