Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K150487 |
Device Name |
X-Suit NIR Biliary Metallic Stent |
Applicant |
MEDINOL LTD. |
KIRYAT ATIDIM, BUILDING 8 |
TEL AVIV,
IL
6158101
|
|
Applicant Contact |
Michal Hershkovitz |
Correspondent |
CARDIOMED DEVICE CONSULTANTS, LLC |
5523 RESEARCH PARK DRIVE |
SUITE 360 |
BALTIMORE,
MD
21228
|
|
Correspondent Contact |
H. Semih Oktay |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 02/25/2015 |
Decision Date | 02/12/2016 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|