Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K063532 |
Device Name |
BARD E LUMINEXX BILIARY STENT |
Applicant |
BARD PERIPHERAL VASCULAR, INC. |
P.O. BOX 1740 |
TEMPE,
AZ
85280 -1740
|
|
Applicant Contact |
LINDSAY K PACK |
Correspondent |
BARD PERIPHERAL VASCULAR, INC. |
P.O. BOX 1740 |
TEMPE,
AZ
85280 -1740
|
|
Correspondent Contact |
LINDSAY K PACK |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/22/2006 |
Decision Date | 05/30/2008 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|