Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K083374 |
Device Name |
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
Marybeth Gamber |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
Marybeth Gamber |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/13/2008 |
Decision Date | 04/22/2009 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00713427
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|