Xlumena
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Xlumena makes
Xlumena manufactures the NAVIX Access Device, a medical instrument designed for vascular access procedures, facilitating precise and controlled insertion into blood vessels.
The NAVIX Access Device is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Axios Stent And Delivery System Ref DEN130007
De Novo 510(k)Navix Access Device Ref K093279
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Xlumena, initiated on 2013-04-17. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 17 Apr 2013 Z-2167-2013 Class II Terminated A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Full distribution text
- 17 Apr 2013 Z-2167-2013 Class II Terminated A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Frequently asked questions
How many devices does Xlumena have in the registry?
The registry currently lists 3 devices for Xlumena. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xlumena's devices?
Among its 3 most recently registered devices, Xlumena has devices listed in FDA 510(k) (3 devices).
What risk classes do Xlumena's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Xlumena's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Xlumena?
FDA recall records list 1 recall initiated by Xlumena, the most recent initiated on 2013-04-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Xlumena in the registry?
The most recently registered devices listed for Xlumena include AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT), AXIOS STENT AND DELIVERY SYSTEM and NAVIX ACCESS DEVICE.