Argon Medical Devices, Inc. · Class II · Cleared Feb 5, 2026
| K-number | K260028 |
| Device name | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister |
| Applicant | Argon Medical Devices, Inc. |
| Product code | QEW |
| Device class | Class II |
| Decision date | Feb 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The CLEANER™ Vac Thrombectomy System is a single-use device for removing fresh, soft blood clots and emboli from peripheral veins and infusing physician-selected fluids like thrombolytics. It consists of an aspiration catheter with handpiece and an external vacuum canister, and is explicitly not intended for pulmonary embolism treatment.
The device modification involves a change to the shipping/distribution configuration of the aspiration canister and addition of an indication for use for that component. No changes were made to design, principle of operation, or intended use compared to the predicate device K232679.
ISO 13485 (design controls, nonconforming product, CAPA), ISO 14971:2019 (risk management), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, pyrogen, acute toxicity, hemocompatibility), IEC-60601 (electrical safety compliance), and ASTM hemolysis assay methods.
There is no change in intended use or fundamental scientific technology between the modified device and predicate K232679. The aspiration canister's functionality and role as a vacuum source remain unchanged; only distribution configuration and labeling were modified. Verification testing confirmed all acceptance criteria were met, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov