# K262538: Artix™ MT;Artix™ Thin-Walled Sheath

- Pathway: 510(k) (Special)
- Applicant: Inari Medical, Inc.
- Decided: Aug 21, 2026 after 29 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K901627 (1990). 48 ancestors in all.
No later device cites it as a predicate yet.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath, Inari Medical, Inc. (2024) Summary page 5.

## Indications for use
The Artix™ MT thrombectomy device is indicated for: The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature. The Artix™ Thin-Walled Sheath is indicated for: The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Use as a conduit for endovascular devices. Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures. The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K262538
Methodology: https://510kreport.com/methodology