Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K173035 |
Device Name |
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Applicant Contact |
Erum B. Nasir |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47402
|
|
Correspondent Contact |
Erum B. Nasir |
Regulation Number | 876.5010
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/28/2017 |
Decision Date | 05/01/2018 |
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
|
|
|