Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K011881 |
Device Name |
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM |
Applicant |
GUIDANT CORP. |
26531 YNEZ RD. |
TEMECULA,
CA
92591 -4630
|
|
Applicant Contact |
SABA MODJARRAD |
Correspondent |
GUIDANT CORP. |
26531 YNEZ RD. |
TEMECULA,
CA
92591 -4630
|
|
Correspondent Contact |
SABA MODJARRAD |
Regulation Number | 876.5010 |
Classification Product Code |
|
Date Received | 06/18/2001 |
Decision Date | 07/18/2001 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|