Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K011817 |
Device Name |
BRIDGE FX |
Applicant |
MEDTRONIC AVE, INC. |
2170 NORTHPOINT PKWY. |
SANTA ROSA,
CA
95407
|
|
Applicant Contact |
JOHN RIOLO |
Correspondent |
MEDTRONIC AVE, INC. |
2170 NORTHPOINT PKWY. |
SANTA ROSA,
CA
95407
|
|
Correspondent Contact |
JOHN RIOLO |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 06/11/2001 |
Decision Date | 08/22/2001 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|