Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K191609 |
Device Name |
Tria Soft Ureteral Stent |
Applicant |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Applicant Contact |
Justin Kapitan |
Correspondent |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Justin Kapitan |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 06/17/2019 |
Decision Date | 08/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|