Cleared Traditional

Mini-ClotTriever Thrombectomy System

K220887 · Inari Medical · Cardiovascular

Aug 2022

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K220887 is an FDA 510(k) clearance for the Mini-ClotTriever Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on August 4, 2022, 129 days after receiving the submission on March 28, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K220887 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2022
Decision Date	August 04, 2022
Days to Decision	129 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.