Cleared Traditional

Aventus Thrombectomy System

K232730 · Inquis Medical · Cardiovascular

Nov 2023

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K232730 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 (Redwood City, US). The FDA issued a Cleared decision on November 1, 2023, 55 days after receiving the submission on September 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K232730 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2023
Decision Date	November 01, 2023
Days to Decision	55 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.