Cleaner Plus Thrombectomy System
by Argon Medical Devices, Inc.
510(k) K211798
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211798 | Date24 Feb 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QEW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5150
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cleaner Plus Thrombectomy System is a Peripheral Mechanical Thrombectomy With Aspiration device, designed for mechanical removal of thrombi in peripheral venous vasculature. It combines aspiration and selective infusion capabilities to facilitate clot clearance while allowing controlled delivery of thrombolytic agents or other physician-specified fluids.
This single-use system is intended for use in interventional radiology or cardiology settings, where it is manually operated under direct visualization. It is classified as a Class II device under FDA regulations (870.5150) and has received FDA 510K clearance as substantially equivalent to predicate devices. The system is non-sterile prior to use and must be sterilized by the facility prior to first use, adhering to standard medical device reprocessing protocols.
From the manufacturer
CLEANER Vac® Thrombectomy System is a single-use aspiration thrombectomy option designed for control, trackable navigation, and efficient device exchange.
CLEANER™ Rotational Thrombectomy System by Argon is designed for AV access and peripheral vessels, and delivers higher patency rates and faster procedures.
Other devices from Argon Medical Devices, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the Cleaner Plus Thrombectomy System intended for use in, and how is it operated?
The Cleaner Plus Thrombectomy System is designed for use in interventional radiology or cardiology settings. It is manually operated under direct visualization, meaning the procedure requires real-time imaging guidance to ensure precise placement and operation within peripheral venous vasculature.
Is the Cleaner Plus Thrombectomy System single-use or reusable, and what preparation is required before first use?
The Cleaner Plus Thrombectomy System is a single-use device, but it is non-sterile prior to use. Facilities must sterilize it according to standard medical device reprocessing protocols before its first use, ensuring compliance with clinical sterility standards.
What unique features does the Cleaner Plus Thrombectomy System offer compared to other thrombectomy devices?
The Cleaner Plus Thrombectomy System combines mechanical removal of thrombi with aspiration capabilities, allowing controlled delivery of fluids like thrombolytics or other physician-specified agents. This dual-function approach helps facilitate clot clearance while enabling targeted treatment during the procedure.
How is the Cleaner Plus Thrombectomy System regulated, and what does its classification mean for clinical use?
The device is classified as a Class II medical device under FDA regulations (product code QEW, category 870.5150) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. This classification indicates it undergoes stricter review than Class I devices but does not require the same pre-market approval process as Class III devices, ensuring it meets established safety and performance standards for mechanical thrombectomy.