Cleared Special

CLEANER? Vac Thrombectomy System, CLEANER? Vac Aspiration Catheter with Handpiece, CLEANER? Vac Aspiration Canister

K260028 · Argon Medical Devices, Inc. · Cardiovascular

Feb 2026

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K260028 is an FDA 510(k) clearance for the CLEANER? Vac Thrombectomy System, CLEANER? Vac Aspiration Catheter with Handpiece, CLEANER? Vac 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 February 5, 2026, 31 days after receiving the submission on January 5, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K260028 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2026
Decision Date	February 05, 2026
Days to Decision	31 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.