The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp's Femoral Vein Catheters.
| Device ID | K860810 |
| 510k Number | K860810 |
| Device Name: | MEDCOMP'S FEMORAL VEIN CATHETERS |
| Classification | Catheter, Femoral |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Elisabeth Walters |
| Correspondent | Elisabeth Walters MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | LFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-08 |