Cleared Traditional

Artix? MT; Artix? Thin-Walled Thrombectomy Sheath

K241894 · Inari Medical, Inc. · Cardiovascular

Oct 2024

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K241894 is an FDA 510(k) clearance for the Artix? MT; Artix? Thin-Walled Thrombectomy Sheath, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 15, 2024, 109 days after receiving the submission on June 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K241894 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2024
Decision Date	October 15, 2024
Days to Decision	109 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.