The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renalfo Hemofilter Cavhd.
| Device ID | K854011 |
| 510k Number | K854011 |
| Device Name: | RENALFO HEMOFILTER CAVHD |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
| Contact | Leroy Fischbach |
| Correspondent | Leroy Fischbach RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-11-05 |