Cleared Traditional

ClotTriever Thrombectomy System

K210689 · Inari Medical, Inc. · Cardiovascular

May 2021

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K210689 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 May 12, 2021, 65 days after receiving the submission on March 8, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K210689 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2021
Decision Date	May 12, 2021
Days to Decision	65 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.