Cleared Special

ClotTriever Sheath

K233815 · Inari Medical, Inc. · Cardiovascular

Dec 2023

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K233815 is an FDA 510(k) clearance for the ClotTriever Sheath, 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 December 18, 2023, 18 days after receiving the submission on November 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K233815 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2023
Decision Date	December 18, 2023
Days to Decision	18 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.