Device Classification Name |
catheter, hemodialysis, triple lumen, non-implanted
|
510(k) Number |
K183219 |
Device Name |
Trio-CT Triple Lumen Catheter |
Applicant |
Medical Components Inc. (dba MedComp) |
1499 Delp Drive |
Harleysville,
PA
19438
|
|
Applicant Contact |
Courtney Nix |
Correspondent |
Medical Components Inc. (dba MedComp) |
1499 Delp Drive |
Harleysville,
PA
19438
|
|
Correspondent Contact |
Courtney Nix |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 11/20/2018 |
Decision Date | 06/14/2019 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|