Cleared Special

K260028 - CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260028 · Argon Medical Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
31d
Days
Class 2
Risk

K260028 is an FDA 510(k) clearance for the CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handp.... Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on February 5, 2026 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Argon Medical Devices, Inc. devices

Submission Details

510(k) Number K260028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 140
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K260028.
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
RoVo Mechanical Thrombectomy System
K253730 · Verge Medical, Inc. · Jan 2026
Sangria™ Thrombectomy System
K251207 · Avantec Vascular Corporation · Jan 2026
Helo Thrombectomy System
K252956 · Endovascular Engineering, Inc. · Dec 2025
Akura Thrombectomy System
K251070 · Akura Medical · Nov 2025