The following data is part of a premarket notification filed by Medical Components, Inc. (dba Medcomp) with the FDA for 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 Hemo.
| Device ID | K173667 |
| 510k 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 Hemo |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Medical Components, Inc. (Dba Medcomp) 1499 Delp Drive Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix Medical Components, Inc. (Dba Medcomp) 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 | 2017-11-30 |
| Decision Date | 2018-05-17 |
| Summary: | summary |