Cleared Traditional

Aventus Thrombectomy System (IM-2001/IM-0002)

K240117 · Inquis Medical · Cardiovascular

Mar 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K240117 is an FDA 510(k) clearance for the Aventus Thrombectomy System (IM-2001/IM-0002), 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 15, 2024, 59 days after receiving the submission on January 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K240117 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2024
Decision Date	March 15, 2024
Days to Decision	59 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.