Medical Device Manufacturer · US , Mountain View , CA

Xlumena, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2013
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Xlumena, Inc. Gastroenterology & Urology ✕
2 devices
1-2 of 2
Cleared Apr 23, 2014
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND...
K140561 · PCU
Gastroenterology & Urology · 49d
Not Cleared Dec 18, 2013
AXIOS STENT AND DELIVERY SYSTEM
DEN130007 · PCU
Gastroenterology & Urology · 302d
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