Artix MT;Artix Thin-Walled Sheath
FDA 510(k) K262538 · Inari Medical, Inc.
510(k) numberK262538
Submission
- Device name
- Artix MT;Artix Thin-Walled Sheath
- Applicant
- Inari Medical, Inc.
Irvine, CA, US - Received
- July 23, 2026
- Decision date
- August 21, 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 |
| 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 |
| K253323 | Protrieve SheathQEW · Special | Inari Medical | 10/29/2025SE |
More from Inari Medical
| 510(k) | Device | Decision |
|---|---|---|
| K252508 | Intri26 Introducer SheathDYB · Traditional | 12/17/2025SE |
| K253323 | Protrieve SheathQEW · Special | 10/29/2025SE |
| K250421 | InThrill Thrombectomy SystemQEW · Traditional | 05/12/2025SE |
| K250088 | FlowTriever2 CatheterQEW · Traditional | 03/13/2025SE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy SheathQEW · Traditional | 10/15/2024SE |
| K242557 | ClotTriever XL Catheter (41-102)QEW · Special | 09/27/2024SE |
| K233069 | Removal System Large Bore 60 cc SyringePUR · Traditional | 03/26/2024SE |
| K234034 | VenaCore Thrombectomy Catheter (46-101)QEW · Traditional | 02/09/2024SE |
| K233815 | ClotTriever SheathQEW · Special | 12/18/2023SE |
| K233646 | Intri24 Introducer Sheath (52-101)DYB · Special | 12/12/2023SE |
Questions and answers
When was Artix MT;Artix Thin-Walled Sheath cleared by the FDA?
Artix MT;Artix Thin-Walled Sheath (K262538) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 29 days after the submission was received.
What is the product code of K262538?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.