The following data is part of a premarket notification filed by Medcomp with the FDA for Pro-line Ct Power Injectable Cvc, Models Ctlines5s, Ctline6d.
| Device ID | K053345 |
| 510k Number | K053345 |
| Device Name: | PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP 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 | 2005-12-02 |
| Decision Date | 2006-03-17 |
| Summary: | summary |