Cleared Traditional

ClotTriever BOLD Catheter

K230494 · Inari Medical, Inc. · Cardiovascular

Apr 2023

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K230494 is an FDA 510(k) clearance for the ClotTriever BOLD 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 18, 2023, 54 days after receiving the submission on February 23, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K230494 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2023
Decision Date	April 18, 2023
Days to Decision	54 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.