The following data is part of a premarket notification filed by Medical Components Inc. (dba Medcomp) with the FDA for Duo-flow Side X Side Double Lumen Catheter.
| Device ID | K192807 |
| 510k Number | K192807 |
| Device Name: | Duo-Flow Side X Side Double Lumen Catheter |
| Classification | Catheter, Hemodialysis, 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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-04-23 |