Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K011506 |
Device Name |
OMNILINK .035 BILIARY STENT SYSTEM |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Applicant Contact |
CURTIS TRUESDALE |
Correspondent |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Correspondent Contact |
CURTIS TRUESDALE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 05/16/2001 |
Decision Date | 06/15/2001 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|