Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K122546 |
Device Name |
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
Applicant |
IDEV TECHNOLOGIES, INC. |
253 Medical Center Blvd. |
Webster,
TX
77598
|
|
Applicant Contact |
DARLENE GARNER |
Correspondent |
IDEV TECHNOLOGIES, INC. |
253 Medical Center Blvd. |
Webster,
TX
77598
|
|
Correspondent Contact |
DARLENE GARNER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 12/07/2012 |
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
|
|
|