Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K991533 |
Device Name |
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION |
Applicant |
PERIPHERAL AVE |
2330 CIRCADIAN WAY |
SANTA ROSA,
CA
95403 -5415
|
|
Applicant Contact |
SUSAN WALTON |
Correspondent |
PERIPHERAL AVE |
2330 CIRCADIAN WAY |
SANTA ROSA,
CA
95403 -5415
|
|
Correspondent Contact |
SUSAN WALTON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 05/03/1999 |
Decision Date | 07/29/1999 |
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
|
|
|