Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K030638 |
Device Name |
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML |
Applicant |
AVANTEC VASCULAR CORP. |
1049 KIEL CT. |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
JAMES M SHY |
Correspondent |
AVANTEC VASCULAR CORP. |
1049 KIEL CT. |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
JAMES M SHY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 02/28/2003 |
Decision Date | 07/09/2003 |
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
|
|
|