Cleaner Rotational Thrombectomy System
FDA 510(k) K141617 · Rex Medical, L.P.
510(k) numberK141617
Submission
- Device name
- Cleaner Rotational Thrombectomy System
- Applicant
- Rex Medical, L.P.
Great Neck, NY, US - Received
- June 17, 2014
- Decision date
- November 14, 2014
- 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.
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|---|---|---|---|
| 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 |
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| K212351 | Revolution Peripheral Atherectomy SystemMCW · Traditional | 12/15/2021SE |
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| K173389 | Rex Medical Aspiration PumpBTA · Traditional | 01/30/2018SE |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm SystemDTK · Traditional | 04/16/2015SE |
| K133243 | Option Elite Vena Cava Filter SystemDTK · Traditional | 12/17/2013SE |
| K060904 | Cleaner Rotational Thrombectomy SystemMCW · Special | 04/28/2006SE |
| K042399 | Modification to Short Introducer SheathDYB · Special | 12/17/2004SE |
Questions and answers
When was Cleaner Rotational Thrombectomy System cleared by the FDA?
Cleaner Rotational Thrombectomy System (K141617) received a 510(k) decision of Substantially Equivalent on November 14, 2014, 150 days after the submission was received.
What is the product code of K141617?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.