Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060
FDA 510(k) K041374 · Idev Technologies, Inc.
510(k) numberK041374
Submission
- Device name
- Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060
- Applicant
- Idev Technologies, Inc.
Houston, TX, US - Received
- May 24, 2004
- Decision date
- March 2, 2005
- 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 |
|---|---|---|
| K130591 | Supera VeritasFGE · Traditional | 05/02/2013SESU |
| K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 12/07/2012SESU |
| K111627 | Supera Veritas(R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 08/21/2012SESU |
| K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsFGE · Traditional | 10/19/2011SESU |
| K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 10/05/2010SESU |
| K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…FGE · Traditional | 01/31/2008SESU |
| K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery CATHETER-SS06120060FGE · Traditional | 08/15/2006SESU |
| K050926 | Texan Longhorn Foreign Body Retrieval Device, Model TX30120060MMX · Special | 05/09/2005SE |
| K033188 | Texan Foreign Body Retrieval Device, Model TX30060050MMX · Traditional | 11/19/2003SE |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060MCW · Traditional | 09/16/2003SE |
Questions and answers
When was Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060 cleared by the FDA?
Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060 (K041374) received a 510(k) decision of Substantially Equivalent on March 2, 2005, 282 days after the submission was received.
What is the product code of K041374?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.