# K193034: AXS Infinity LS Plus Long Sheath

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Nov 29, 2019 after 29 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: 8 generations back to K010954 (2001). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm, Inneuroco, Inc. (2017) Summary page 5.

## Most influential descendants
- K241637: Echo Intracranial Base Catheter (2024), 0 descendants of its own

## Indications for use
The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K193034
Methodology: https://510kreport.com/methodology