Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181905
Device Classification Name
More FDA Info for this Device
510(K) Number
K181905
Device Name
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Kayla Mackey
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PCU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2018
Decision Date
03/25/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact