Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K180485 |
Device Name |
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender |
Applicant |
Covidien, llc |
15 Hampshire Street |
Mansfield,
MA
02048
|
|
Applicant Contact |
Carol Ming |
Correspondent |
Covidien, llc |
15 Hampshire Street |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Carol Ming |
Regulation Number | 876.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/2018 |
Decision Date | 07/27/2018 |
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
|
|
|