CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
FDA 510(k) K260028 · Argon Medical Devices, Inc.
510(k) numberK260028
Submission
- Device name
- CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- January 5, 2026
- Decision date
- February 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEW – Peripheral Mechanical Thrombectomy With Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Other 510(k)s with product code QEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261800 | Helo Max Thrombectomy System (HEL2090)QEW · Traditional | Endovascular Engineering | 09/03/2026SE |
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | Inari Medical, Inc. | 08/21/2026SE |
| K261523 | Vertex Thrombectomy SystemQEW · Traditional | Jupiter Endovascular | 08/04/2026SE |
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | Penumbra, Inc. | 04/24/2026SE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | Penumbra, Inc. | 02/05/2026SE |
| K253730 | RoVo Mechanical Thrombectomy SystemQEW · Special | Verge Medical, Inc. | 01/21/2026SE |
| K251207 | Sangria Thrombectomy SystemQEW · Traditional | Avantec Vascular Corporation | 01/07/2026SE |
| K252956 | Helo Thrombectomy SystemQEW · Traditional | Endovascular Engineering, Inc. | 12/18/2025SE |
| K251070 | Akura Thrombectomy SystemQEW · Traditional | Akura Medical | 11/25/2025SE |
| K253323 | Protrieve SheathQEW · Special | Inari Medical | 10/29/2025SE |
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| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner…QEW · Traditional | 03/28/2024SE |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece…QEW · Traditional | 01/19/2024SE |
| K233432 | 10F Sheath and Dilator SetDYB · Traditional | 12/08/2023SE |
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Questions and answers
When was CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister cleared by the FDA?
CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister (K260028) received a 510(k) decision of Substantially Equivalent on February 5, 2026, 31 days after the submission was received.
What is the product code of K260028?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.