Thrombectomy devices
Cleaner Plus
by Argon Medical Devices, Inc.
A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.
Cleaner Plus models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 70001510 | — | Not stated | Available |
| 70001512 | — | Not stated | Available |
| 70011510 | — | Not stated | Available |
| 70011512 | — | Not stated | Available |
| 70070018 | — | Not stated | Available |
| 70070400 | — | Not stated | Available |
| 70071500 | — | Not stated | Available |
| 70071518 | — | Not stated | Available |
FDA clearances
- 510(k) K233909 March 2024
- 510(k) K211798 February 2022
Procedures that use thrombectomy devices
Frequently asked questions
What is Cleaner Plus used for?
A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.
Who makes Cleaner Plus?
Cleaner Plus is made by Argon Medical Devices, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Cleaner Plus come in?
The FDA device database does not list sizes for Cleaner Plus. Check the instructions for use or ask a Argon Medical Devices, Inc. representative.
Is Cleaner Plus MRI safe?
The FDA device database entry for Cleaner Plus does not state its MRI safety status. Check the labeling before MRI.
Is Cleaner Plus FDA cleared?
Cleaner Plus is covered by FDA submissions K233909, K211798.
How do I contact a Argon Medical Devices, Inc. sales representative?
Argon Medical Devices, Inc. has not listed representatives on LA Vascular yet. Visit the Argon Medical Devices, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.