Cleared Traditional

VenaCore Thrombectomy Catheter (46-101)

K234034 · Inari Medical, Inc. · Cardiovascular

Feb 2024

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K234034 is an FDA 510(k) clearance for the VenaCore Thrombectomy Catheter (46-101), 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 February 9, 2024, 51 days after receiving the submission on December 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K234034 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2023
Decision Date	February 09, 2024
Days to Decision	51 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.