Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K202176 |
Device Name |
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes |
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 | 08/04/2020 |
Decision Date | 09/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|