Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K071646 |
Device Name |
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 |
Applicant |
IDEV TECHNOLOGIES, INC. |
1120 NASA PKWY., SUITE 600 |
HOUSTON,
TX
77058
|
|
Applicant Contact |
TIMOTHY R PLACEK |
Correspondent |
IDEV TECHNOLOGIES, INC. |
1120 NASA PKWY., SUITE 600 |
HOUSTON,
TX
77058
|
|
Correspondent Contact |
TIMOTHY R PLACEK |
Regulation Number | 876.5010 |
Classification Product Code |
|
Date Received | 06/18/2007 |
Decision Date | 01/31/2008 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|