The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Ct Midline.
| Device ID | K141151 |
| 510k Number | K141151 |
| Device Name: | CT MIDLINE |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-07-08 |
| Summary: | summary |