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Xlumena, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2167-2013Class IIXlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, ProductApril 17, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K140561AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM April 23, 2014
DEN130007AXIOS STENT AND DELIVERY SYSTEMDecember 18, 2013
K093279NAVIX ACCESS DEVICEApril 7, 2010