Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K031331 |
Device Name |
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM |
Applicant |
ABBOTT VASCULAR INC. |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
JOANNA KUSKOWSKI |
Correspondent |
ABBOTT VASCULAR INC. |
400 Saginaw Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
JOANNA KUSKOWSKI |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/28/2003 |
Decision Date | 08/12/2003 |
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
|
|
|