Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K062264 |
Device Name |
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
JENNIFER HACKNEY |
Correspondent |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
JENNIFER HACKNEY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 08/04/2006 |
Decision Date | 11/08/2007 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|