The following data is part of a premarket notification filed by Medical Components, Inc. (dba Medcomp) with the FDA for Ct Midline.
| Device ID | K170770 |
| 510k Number | K170770 |
| Device Name: | CT Midline |
| Classification | Midline Catheter |
| 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 | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-14 |
| Decision Date | 2017-07-25 |
| Summary: | summary |