# K260028: CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister

- Pathway: 510(k) (Special)
- Applicant: Argon Medical Devices, Inc.
- Decided: Feb 5, 2026 after 31 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003410 (2001). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232679: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister, Argon Medical Devices, Inc. (2024) Summary page 5.

## Indications for use
The CLEANER™ Vac Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The CLEANER™ Vac Thrombectomy System is not intended for use in the pulmonary vasculature for treating pulmonary embolism. The CLEANER™ Vac Aspiration Canister is indicated as a vacuum source for the CLEANER™ Vac Thrombectomy System.

Source page: https://510kreport.com/device/K260028
Methodology: https://510kreport.com/methodology