Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K060057 |
Device Name |
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM |
Applicant |
EV3 INC. |
4600 NATHAN LN. NORTH |
PLYMOUTH,
MN
55442 -2920
|
|
Applicant Contact |
MELISSA SOMMERFELD |
Correspondent |
EV3 INC. |
4600 NATHAN LN. NORTH |
PLYMOUTH,
MN
55442 -2920
|
|
Correspondent Contact |
MELISSA SOMMERFELD |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/09/2006 |
Decision Date | 03/08/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|