# K211798: Cleaner Plus Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Feb 24, 2022 after 259 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: 10 generations back to K954234 (1995). 28 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141617: Cleaner Rotational Thrombectomy System, Rex Medical, L.P. (2014) Summary page 4.

## Most influential descendants
- K223891: Cobra Catheter System (2023), 2 descendants of its own
- K252956: Helo Thrombectomy System (2025), 1 descendant of its own
- K261800: Helo Max Thrombectomy System (HEL2090) (2026), 0 descendants of its own
- K233909: Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (2024), 0 descendants of its own
- K223176: Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister (2023), 0 descendants of its own

## Indications for use
The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

Source page: https://510kreport.com/device/K211798
Methodology: https://510kreport.com/methodology