Cleared Traditional

Cleaner? Plus 18F Thrombectomy System - Cleaner? Plus 18F Aspiration Catheter, Cleaner? Plus 18F Handpiece with Maceration Wire, Cleaner? Plus 18F Aspiration Canister

K233909 · Argon Medical Devices, Inc. · Cardiovascular

Mar 2024

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K233909 is an FDA 510(k) clearance for the Cleaner? Plus 18F Thrombectomy System - Cleaner? Plus 18F Aspiration Catheter, Cleaner? Plus 18F Handpiece with Maceration Wire, Cleaner? Plus 18F Aspiration Canister, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on March 28, 2024, 107 days after receiving the submission on December 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K233909 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2023
Decision Date	March 28, 2024
Days to Decision	107 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.