Cleared Traditional

ClotTriever XL Catheter

K223210 · Inari Medical, Inc. · Cardiovascular

Apr 2023

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K223210 is an FDA 510(k) clearance for the ClotTriever XL Catheter, 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 April 27, 2023, 192 days after receiving the submission on October 17, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K223210 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2022
Decision Date	April 27, 2023
Days to Decision	192 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.