Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K173667 |
Device Name |
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm |
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 | 11/30/2017 |
Decision Date | 05/17/2018 |
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
|
|
|