Renal Systems, Inc.
Medical device manufacturer in Minneapolis, MN.
35510(k) clearances
0PMA approvals
0recalls
Device types
- FIQ Cannula, A-V Shunt 6
- LIF Dialyzer Reprocessing System 6
- KOC Accessories, Blood Circuit, Hemodialysis 4
- FKQ System, Dialysate Delivery, Central… 4
- FJI Dialyzer, Capillary, Hollow Fiber 3
- KPO Dialysate Concentrate For Hemodialysis… 2
- KNZ Accessories, A-V Shunt 2
- KDI Dialyzer, High Permeability With Or Without… 2
- FLB Meter, Conductivity, Induction, Remote Type 1
- FIR Pump, Blood, Extra-Luminal 1
- FKR Subsystem, Proportioning 1
- LFJ Catheter, Subclavian 1
- FKX System, Peritoneal, Automatic Delivery 1
- MSF Hemodialyzer, Re-Use, High Flux 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844790 | Renaflo HemoconcentratorKDI · Traditional | 05/23/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
| K840436 | Hemasite/Renaloy -Vascular Access ShuntFIQ · Traditional | 02/21/1984SE |
| K834596 | Blood TubingKOC · Traditional | 02/04/1984SE |
| K834510 | Renaflo Avf Set for HemodialysisKNZ · Traditional | 02/04/1984SE |
| K833622 | Renalloy Hemasite Vascular Access ShuntFIQ · Traditional | 11/29/1983SE |
| K833181 | HPR Home Patient RenatronLIF · Traditional | 10/27/1983SE |
| K830575 | Renalin (TentativeLIF · Traditional | 03/31/1983SE |
| K830574 | Renatron Dialyzer Reprocessing SysLIF · Traditional | 03/29/1983SE |
| K823546 | Renaflo IIKOC · Traditional | 12/16/1982SE |
| K822880 | Arterio Venous Shunt Cannula & AdaptorsFIQ · Traditional | 10/18/1982SE |
| K821001 | Mcparland Scalp Vein CatheterLFJ · Traditional | 07/22/1982SE |
| K820221 | Hydrogen Peroxide Topical; FormaldehydeLIF · Traditional | 03/23/1982SE |
| K813237 | Hemasite Vascular Access Shunt HM-1000FIQ · Traditional | 11/30/1981SE |
| K812890 | Hemasite Graftless Vascular AcessFIQ · Traditional | 11/16/1981SE |
| K812230 | Model RS 8300LIF · Traditional | 11/06/1981SE |
| K811977 | Hemasite Access Monitor (Tent.) #RS-8200KOC · Traditional | 07/31/1981SE |
| K811384 | Hemasite Vascular Access ShuntFIQ · Traditional | 07/31/1981SE |
| K802465 | Bicarb-O-Mate Hemodialysis Sod. Bicarb.FKR · Traditional | 11/12/1980SE |
| K801827 | Renaflo Hollow Fiber Dialyzer #100.1FJI · Traditional | 09/26/1980SE |
| K801826 | Renaflo Hollow Fiber Dialyzers #Mp 140FJI · Traditional | 09/26/1980SE |
| K801825 | Renaflo Hollow Fiber Dialyzers S.M.A.D.FJI · Traditional | 09/26/1980SE |
| K792213 | Renal Systems Hemodialysis ConcentrateKPO · Traditional | 01/04/1980SE |
| K781967 | Hemodialysis Concentrate, SodiuKPO · Traditional | 12/07/1978SE |
| K771705 | RS-7800 MinipumpFIR · Traditional | 10/04/1977SE |
| K770524 | Transducer Protector, RT-901, RT-902KOC · Traditional | 03/30/1977SE |
| K770263 | Dialysate Meter RS-2100A, Circuit ChangeFLB · Traditional | 02/18/1977SE |