Xlumena, Inc.

Medical device manufacturer in Mountain View, CA.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K140561Axios Stent and Delivery System (with 10MM X 10MM Stent) Axios Stent and Delivery System…PCU · Special 04/23/2014SE
K093279Navix Access DeviceGCJ · Traditional 04/07/2010SE

Recalls

RecallProductInitiated
Z-2167-2013 Class IIXlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number:…A complaint investigation has found that product fractures can occur at the distal end of the catheter under… 04/17/2013Terminated