Cleared Traditional

ClotTriever Thrombectomy System

K221531 · Inari Medical, Inc. · Cardiovascular

Feb 2023

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K221531 is an FDA 510(k) clearance for the ClotTriever Thrombectomy System, 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 February 6, 2023, 256 days after receiving the submission on May 26, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K221531 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 2022
Decision Date	February 06, 2023
Days to Decision	256 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.