The following data is part of a premarket notification filed by Medcomp with the FDA for Medcomp Bio-cath Catheter Line.
| Device ID | K003110 |
| 510k Number | K003110 |
| Device Name: | MEDCOMP BIO-CATH CATHETER LINE |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Florence A Caikoski |
| Correspondent | Florence A Caikoski 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 | 2000-10-04 |
| Decision Date | 2000-12-01 |