Cleared Special

Triever16 Curve

K223419 · Inari Medical · Cardiovascular

Mar 2023

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K223419 is an FDA 510(k) clearance for the Triever16 Curve, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on March 23, 2023, 133 days after receiving the submission on November 10, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K223419 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2022
Decision Date	March 23, 2023
Days to Decision	133 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.