Cleared Special

ClotTriever XL Catheter (41-102)

K242557 · Inari Medical, Inc. · Cardiovascular

Sep 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K242557 is an FDA 510(k) clearance for the ClotTriever XL Catheter (41-102), 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 September 27, 2024, 30 days after receiving the submission on August 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K242557 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2024
Decision Date	September 27, 2024
Days to Decision	30 days
Submission Type	Special
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.