Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K111766 |
Device Name |
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS |
Applicant |
IDEV TECHNOLOGIES, INC. |
253 MEDICAL CENTER BLVD |
WEBSTER,
TX
77598
|
|
Applicant Contact |
DARENE GARNER |
Correspondent |
IDEV TECHNOLOGIES, INC. |
253 MEDICAL CENTER BLVD |
WEBSTER,
TX
77598
|
|
Correspondent Contact |
DARENE GARNER |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 06/23/2011 |
Decision Date | 10/19/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|