Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K001258 |
Device Name |
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM |
Applicant |
CORDIS CORP. |
7 POWDER HORN DR. |
WARREN,
NJ
07059
|
|
Applicant Contact |
DEAN A KNIGHT |
Correspondent |
CORDIS CORP. |
7 POWDER HORN DR. |
WARREN,
NJ
07059
|
|
Correspondent Contact |
DEAN A KNIGHT |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/18/2000 |
Decision Date | 06/27/2000 |
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
|
|
|