The following data is part of a premarket notification filed by Medcomp with the FDA for 15.5f Jet Medical Free Flow Long-term Coaxial Catheter.
| Device ID | K040328 |
| 510k Number | K040328 |
| Device Name: | 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Rosanna Severini |
| Correspondent | Rosanna Severini MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-10 |
| Decision Date | 2004-11-24 |
| Summary: | summary |