Device Classification Name |
pancreatic stent, covered, metallic, removable
|
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
|
|
Applicant Contact |
Kayla Mackey |
Correspondent |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Kayla Mackey |
Regulation Number | 876.5015
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/16/2018 |
Decision Date | 03/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|