# Xlumena, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 3 (2010–2014): 2 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Xlumena, Inc. (2); Xlumena (1)
- Product codes: PCU (2), GCJ (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apollo Endosurgery, Inc.: 1 (https://510kreport.com/company/apollo-endosurgery)
- Wilson-Cook Medical, Inc.: 1 (https://510kreport.com/company/wilson-cook-medical)

## Firms that cite its devices most
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- DEN130007: Axios Stent and Delivery System (2013), cited by 2
- K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) (2014), cited by 2

## Recent decisions
- K140561: Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System (with 15MM X 10MM Stent) (Apr 23, 2014)
- DEN130007: Axios Stent and Delivery System (Dec 18, 2013)
- K093279: Navix Access Device (Apr 7, 2010)

Source page: https://510kreport.com/company/xlumena