Fresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) medical device clearances.
Top product codes for Fresenius Medical Care Renal Therapies Group, LLC
Recent clearances by Fresenius Medical Care Renal Therapies Group, LLC
- K252377 — NxStage System One with NxView
- K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- K253518 — FX CorAL 40; FX CorAL 50
- K250634 — BCM2-Body Composition Monitor
- K250471 — AquaC UNO H
- K251851 — DIASAFEplusUS (F00013010)
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
- K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
- K243505 — 5008X Hemodialysis System
- K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
- K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
- K243874 — FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
- K232953 — AquaBplus; AquaB LITE
- K240394 — multiFlux 1000 (F00012408)
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- K232926 — Novalung ultimate kit (US)
- K231125 — 2008T BlueStar Hemodialysis Machine
- K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
- K213992 — CombiSet Hemodialysis Blood Tubing Set
- K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- K220281 — multiFiltratePRO System
- K222318 — Fresenius Liberty Select Cycler
- K222952 — 2008T BlueStar Hemodailysis Machine
- K212620 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K212522 — Lilliput APD System
- K203062 — Optiflux Series of Dialyzers F160NR, F180NR, F200NR
- K192707 — Optiflux F180NR Dialyzer
- K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
- K192209 — Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
- K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K191474 — NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
- K191407 — Novalung System
- K190459 — Hemoflow F3 and F4 Dialyzers
- K182367 — DIASAFEplusUS
- K181108 — Fresenius Liberty Select Cycler
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K173972 — 2008T BlueStar Hemodialysis Machine
- K173718 — Liberty Cycler Set
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- K173363 — Cycler Drain Bag Set
- K172238 — CAREline Airless Hemodialysis Blood Tubing Sets
- K171652 — Fresenius Liberty Select Cycler
- K162716 — bibag
- K153449 — 2008K2 Hemodialysis Machine
- K160749 — CRIT-LINE III Blood Chamber II
- K150708 — 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K141145 — LIBERTY PDX CYCLER
- K131908 — 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
Data sourced from openFDA. This site is unofficial and independent of the FDA.