# K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Oct 15, 2024 after 109 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K901627 (1990). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220600: Artix Thrombectomy Device, Inari Medical (2022) Summary page 5.
- K230912: Artix BG, Inari Medical (2023) Summary page 9.

## Most influential descendants
- K262538: Artix™ MT;Artix™ Thin-Walled Sheath (2026), 0 descendants of its own

## Recalls of this device
- Apr 8, 2025 · Class II · Z-1728-2025: Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial forc

## Indications for use
The ArtixTM 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 ArtixTM MT thrombectomy device is intended for use in the peripheral vasculature. The ArtixTM 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 ArtixTM Thin-Walled Sheath is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K241894
Methodology: https://510kreport.com/methodology