Xlumena, Inc.

FDA Regulatory Profile

Xlumena, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2167-2013, Class II) was initiated on April 17, 2013. Its most recent 510(k) clearance was granted on April 23, 2014.

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