Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K172588 |
Device Name |
Balloon Catheter and Balloon Ureteral Dilator Set |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Applicant Contact |
Carly Powell |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Correspondent Contact |
Carly Powell |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 08/29/2017 |
Decision Date | 04/19/2018 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|