Sangria Thrombectomy System
FDA 510(k) K251207 · Avantec Vascular Corporation
510(k) numberK251207
Submission
- Device name
- Sangria Thrombectomy System
- Applicant
- Avantec Vascular Corporation
Sunnyvale, CA, US - Received
- April 18, 2025
- Decision date
- January 7, 2026
- 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 |
| 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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| K170987 | Captus Vascular Retrieval SystemMMX · Traditional | 08/28/2017SE |
| K032436 | Duramax .018 Biliary Stent SystemFGE · Traditional | 02/04/2004SESU |
| K030638 | Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80…FGE · Traditional | 07/09/2003SESU |
| K030062 | Admiral .035 Dilatation Catheter, Models ADL0720-80,ADL0720-135,ADL0820-80…LIT · Traditional | 04/03/2003SE |
Questions and answers
When was Sangria Thrombectomy System cleared by the FDA?
Sangria Thrombectomy System (K251207) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 264 days after the submission was received.
What is the product code of K251207?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.