Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K073672 |
Device Name |
SKATER BILIARY CATHETER |
Applicant |
ANGIOTECH |
13921 PARK CENTER ROAD |
SUITE 100 |
HERNDON,
VA
20171
|
|
Applicant Contact |
TRUDY ESTRIDGE |
Correspondent |
ANGIOTECH |
13921 PARK CENTER ROAD |
SUITE 100 |
HERNDON,
VA
20171
|
|
Correspondent Contact |
TRUDY ESTRIDGE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/27/2007 |
Decision Date | 01/24/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|