FDA.reportPublic FDA data

510(k) DEN130007

Device
AXIOS STENT AND DELIVERY SYSTEM
Applicant
Xlumena, Inc.
510(k) number
DEN130007
Product code
PCU
Decision
Unknown (DENG)
Decision date
2013-12-18
Date received
2013-02-19
Regulation
876.5015
Classification name
Pancreatic Stent, Covered, Metallic, Removable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
JANE BEGGS
Address
453 Ravendale Dr., Suite H Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PCU#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.2026-03-13
K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation2022-09-07
K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2021-04-15
K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2019-08-26
K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2019-03-25
K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2017-02-18
K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery SystemBoston Scientific Corporation2015-12-11
K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation2015-10-06
K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp2015-08-05
K140561AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)Xlumena, Inc.2014-04-23