Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K062798 |
Device Name |
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB |
Applicant |
CORDIS CORP. |
7 POWDER HORN DRIVE |
WARREN,
NJ
07059
|
|
Applicant Contact |
KAREN WILK |
Correspondent |
CORDIS CORP. |
7 POWDER HORN DRIVE |
WARREN,
NJ
07059
|
|
Correspondent Contact |
KAREN WILK |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/19/2006 |
Decision Date | 02/06/2008 |
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
|
|
|