Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K173657 |
Device Name |
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Applicant Contact |
Samuel Engelman |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Correspondent Contact |
Chelsea Woods |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/29/2017 |
Decision Date | 08/23/2018 |
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
|
|
|