Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K133110 |
Device Name |
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM |
Applicant |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
RENEE MITCHELL |
Correspondent |
Boston Scientific Corporation |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
RENEE MITCHELL |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 07/02/2014 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|