Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K061235 |
Device Name |
LIFESTENT TURBO BILIARY STENT SYSTEM |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
KEVIN DRISKO |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
KEVIN DRISKO |
Regulation Number | 876.5010 |
Classification Product Code |
|
Date Received | 05/03/2006 |
Decision Date | 06/05/2006 |
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
|
|
|