The following data is part of a premarket notification filed by Medcomp (dba Medical Components, Inc.) with the FDA for Symetrex Long Term Hemodialysis Catheter.
| Device ID | K171618 |
| 510k Number | K171618 |
| Device Name: | Symetrex Long Term Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Medcomp (DBA Medical Components, Inc.) 1499 Delp Drive Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix Medcomp (DBA Medical Components, Inc.) 1499 Delp Drive Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-11-16 |
| Summary: | summary |