# K230912: Artix BG

- Pathway: 510(k) (Special)
- Applicant: Inari Medical
- Decided: May 2, 2023 after 32 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: 18 generations back to K901627 (1990). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223000: Artix BG, Inari Medical (2023) Summary page 4.

## Most influential descendants
- K241894: Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (2024), 1 descendant of its own
- K262538: Artix™ MT;Artix™ Thin-Walled Sheath (2026), 0 descendants of its own

## Indications for use
The Artix BG balloon thrombectomy sheath is indicated for: The non-surgical aspiration 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 retrieval devices. Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K230912
Methodology: https://510kreport.com/methodology