Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K000744 |
Device Name |
MEDTRONIC AVE BRIDGE X3 STENT |
Applicant |
MEDTRONIC AVE, INC. |
2170 NORTHPOINT PKWY. |
SANTA ROSA,
CA
95407
|
|
Applicant Contact |
SUSAN WALTON |
Correspondent |
MEDTRONIC AVE, INC. |
2170 NORTHPOINT PKWY. |
SANTA ROSA,
CA
95407
|
|
Correspondent Contact |
SUSAN WALTON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 03/07/2000 |
Decision Date | 06/05/2000 |
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
|
|
|