The following data is part of a premarket notification filed by Medical Components Inc. (dba Medcomp) with the FDA for 12f Tri-flow Triple Lumen Catheter.
| Device ID | K181175 |
| 510k Number | K181175 |
| Device Name: | 12F Tri-Flow Triple Lumen Catheter |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-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 | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-02 |
| Decision Date | 2018-07-05 |
| Summary: | summary |