Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K182980 |
Device Name |
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent |
Applicant |
Cook Ireland Ltd |
O' Halloran Rd, National Technology Park |
Limerick,
IE
|
|
Applicant Contact |
Cathrina McHale |
Correspondent |
Cook Ireland Ltd |
O' Halloran Rd, National Technology Park |
Limerick,
IE
|
|
Correspondent Contact |
Cathrina McHale |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 10/29/2018 |
Decision Date | 11/16/2018 |
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
|
|
|