Company ยท US
Renal Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1998. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FIQ | Cannula, A-V Shunt | 6 |
| LIF | Dialyzer Reprocessing System | 6 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 3 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 |
| KNZ | Accessories, A-V Shunt | 2 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 2 |
| FIR | Pump, Blood, Extra-Luminal | 1 |
| FKR | Subsystem, Proportioning | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 |
| FLB | Meter, Conductivity, Induction, Remote Type | 1 |
| LFJ | Catheter, Subclavian | 1 |
| MSF | Hemodialyzer, Re-Use, High Flux | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 5, 1998 | K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) Renal Systems, Inc. | MSF |
| Jun 9, 1987 | K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT Renal Systems, Inc. | FKQ |
| Nov 5, 1985 | K854011 | RENALFO HEMOFILTER CAVHD Renal Systems, Inc. | KDI |
| May 23, 1985 | K844790 | RENAFLO HEMOCONCENTRATOR Renal Systems, Inc. | KDI |
| Jan 7, 1985 | K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM Renal Systems, Inc. | FKX |
| Jan 7, 1985 | K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD Renal Systems, Inc. | FKQ |
| Jul 6, 1984 | K842258 | RENATRON Renal Systems, Inc. | LIF |
| May 22, 1984 | K841543 | CONCENTRATE CONDUCTIVITY METER Renal Systems, Inc. | FKQ |
| May 2, 1984 | K840182 | RENAPAK CONCENTRATE MIXING SYS. Renal Systems, Inc. | FKQ |
| Feb 21, 1984 | K840437 | HEMASITE ACCESSORIES MODIFICATION Renal Systems, Inc. | KNZ |
| Feb 21, 1984 | K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT Renal Systems, Inc. | FIQ |
| Feb 4, 1984 | K834596 | BLOOD TUBING Renal Systems, Inc. | KOC |
| Feb 4, 1984 | K834510 | RENAFLO AVF SET FOR HEMODIALYSIS Renal Systems, Inc. | KNZ |
| Nov 29, 1983 | K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT Renal Systems, Inc. | FIQ |
| Oct 27, 1983 | K833181 | HPR HOME PATIENT RENATRON Renal Systems, Inc. | LIF |
| Mar 31, 1983 | K830575 | RENALIN (TENTATIVE Renal Systems, Inc. | LIF |
| Mar 29, 1983 | K830574 | RENATRON DIALYZER REPROCESSING SYS Renal Systems, Inc. | LIF |
| Dec 16, 1982 | K823546 | RENAFLO II Renal Systems, Inc. | KOC |
| Oct 18, 1982 | K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS Renal Systems, Inc. | FIQ |
| Jul 22, 1982 | K821001 | MCPARLAND SCALP VEIN CATHETER Renal Systems, Inc. | LFJ |
| Mar 23, 1982 | K820221 | HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE Renal Systems, Inc. | LIF |
| Nov 30, 1981 | K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 Renal Systems, Inc. | FIQ |
| Nov 16, 1981 | K812890 | HEMASITE GRAFTLESS VASCULAR ACESS Renal Systems, Inc. | FIQ |
| Nov 6, 1981 | K812230 | MODEL RS 8300 Renal Systems, Inc. | LIF |
| Jul 31, 1981 | K811977 | HEMASITE ACCESS MONITOR (TENT.) #RS-8200 Renal Systems, Inc. | KOC |
| Jul 31, 1981 | K811384 | HEMASITE VASCULAR ACCESS SHUNT Renal Systems, Inc. | FIQ |
| Nov 12, 1980 | K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. Renal Systems, Inc. | FKR |
| Sep 26, 1980 | K801827 | RENAFLO HOLLOW FIBER DIALYZER #100.1 Renal Systems, Inc. | FJI |
| Sep 26, 1980 | K801826 | RENAFLO HOLLOW FIBER DIALYZERS #MP 140 Renal Systems, Inc. | FJI |
| Sep 26, 1980 | K801825 | RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. Renal Systems, Inc. | FJI |
| Jan 4, 1980 | K792213 | RENAL SYSTEMS HEMODIALYSIS CONCENTRATE Renal Systems, Inc. | KPO |
| Dec 7, 1978 | K781967 | HEMODIALYSIS CONCENTRATE, SODIU Renal Systems, Inc. | KPO |
| Oct 4, 1977 | K771705 | RS-7800 MINIPUMP Renal Systems, Inc. | FIR |
| Mar 30, 1977 | K770524 | TRANSDUCER PROTECTOR, RT-901, RT-902 Renal Systems, Inc. | KOC |
| Feb 18, 1977 | K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE Renal Systems, Inc. | FLB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||