Cleared Special

Triever20 Curve (21-201)

K231848 · Inari Medical, Inc. · Cardiovascular

Jul 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K231848 is an FDA 510(k) clearance for the Triever20 Curve (21-201), 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 July 21, 2023, 28 days after receiving the submission on June 23, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K231848 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2023
Decision Date	July 21, 2023
Days to Decision	28 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.