Cleared Traditional

FlowTriever2 Catheter

K250088 · Inari Medical, Inc. · Cardiovascular

Mar 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K250088 is an FDA 510(k) clearance for the FlowTriever2 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 March 13, 2025, 58 days after receiving the submission on January 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250088 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2025
Decision Date	March 13, 2025
Days to Decision	58 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.