Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K033834 |
Device Name |
OMNILINK .018 BILIARY STENT SYSTEM |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
MICHELLE GROSSMAN |
Correspondent |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
MICHELLE GROSSMAN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/10/2003 |
Decision Date | 01/02/2004 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|