# K221846: Artix Ballon Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical
- Decided: Jul 11, 2022 after 17 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010954 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153729: 8F FlowGate2 Balloon Guide Catheter, Concentric Medical (2016) Summary page 4.

## Indications for use
The Artix Balloon Guiding 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. The Artix Balloon Guiding Sheath is also indicated for use as a conduit for retrieval devices. The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.

Source page: https://510kreport.com/device/K221846
Methodology: https://510kreport.com/methodology