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510(k) K181905

Device
AXIOS Stent And Delivery System, AXIOS Stent And Electrocautery Enhanced Delivery System
Applicant
Boston Scientific Corporation
510(k) number
K181905
Product code
PCU  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-25
Date received
2018-07-16
Regulation
876.5015
Classification name
Pancreatic Stent, Covered, Metallic, Removable
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kayla Mackey
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
DEN130007AXIOS STENT AND DELIVERY SYSTEMXlumena, Inc.2013-12-18