Cleared Traditional

InThrill? Thrombectomy System

K250421 · Inari Medical, Inc. · Cardiovascular

May 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K250421 is an FDA 510(k) clearance for the InThrill? 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, 2025, 88 days after receiving the submission on February 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250421 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2025
Decision Date	May 12, 2025
Days to Decision	88 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.