# DEN130007: Axios Stent and Delivery System

- Pathway: De Novo (Post-NSE)
- Applicant: Xlumena, Inc.
- Decided: Dec 18, 2013 after 302 days
- Product code: PCU (Pancreatic Stent, Covered, Metallic, Removable)
- Device class: 2
- Regulation: 21 CFR 876.5015
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) (2014), 9 descendants of its own
- K150692: AXIOS Stent with Electrocautery Enhanced Delivery System (2015), 8 descendants of its own
- K152572: AXIOS Stent and Delivery System (2015), 7 descendants of its own
- K153088: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (2015), 6 descendants of its own
- K163272: AXIOS Stent and Electrocautery Enhanced Delivery System (2017), 5 descendants of its own

Source page: https://510kreport.com/device/DEN130007
Methodology: https://510kreport.com/methodology