The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Hemocath I Kidney Dialysis Catheter.
| Device ID | K801968 |
| 510k Number | K801968 |
| Device Name: | HEMOCATH I KIDNEY DIALYSIS CATHETER |
| Classification | Set, Dialysis, Single Needle (co-axial Flow) |
| Applicant | MEDICAL COMPONENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBW |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-09-26 |