Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
FDA 510(k) K232679 · Argon Medical Devices, Inc.
510(k) numberK232679
Submission
- Device name
- Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- September 1, 2023
- Decision date
- January 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special | Argon Medical Devices, Inc. | 02/05/2026SE |
| 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 |
More from Akura Medical
| 510(k) | Device | Decision |
|---|---|---|
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | 02/23/2026SE |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special | 02/05/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | 01/20/2026SE |
| K253741 | VStick Vascular Access SetDYB · Special | 12/15/2025SE |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E)DTK · Special | 09/10/2024SE |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C)DYB · Traditional | 08/01/2024SE |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner…QEW · Traditional | 03/28/2024SE |
| K233432 | 10F Sheath and Dilator SetDYB · Traditional | 12/08/2023SE |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline CathetersLJS · Traditional | 11/30/2023SE |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Special | 09/07/2023SE |
Questions and answers
When was Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister cleared by the FDA?
Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister (K232679) received a 510(k) decision of Substantially Equivalent on January 19, 2024, 140 days after the submission was received.
What is the product code of K232679?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.