Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K203162 |
Device Name |
Advanix Biliary Stent with NaviFlex RX Delivery System |
Applicant |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Applicant Contact |
Elena Hennessey |
Correspondent |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Elena Hennessey |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 10/23/2020 |
Decision Date | 12/18/2020 |
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
|
|
|