# K223000: Artix BG

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical
- Decided: Jan 11, 2023 after 105 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: 17 generations back to K901627 (1990). 26 ancestors in all.
3 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)
- K212632: ClotTriever Thrombectomy System, Inari Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K230912: Artix BG (2023), 2 descendants of its own
- 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: * 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. * Use as a conduit for retrieval devices. * 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. The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K223000
Methodology: https://510kreport.com/methodology