FDA 510(k) Applications Submitted by Fresenius Medical Care Renal Therapies Group, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160749 |
03/18/2016 |
CRIT-LINE III Blood Chamber II |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K220281 |
02/01/2022 |
multiFiltratePRO System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K190459 |
02/26/2019 |
Hemoflow F3 and F4 Dialyzers |
Fresenius Medical Care Renal Therapies Group, LLC |
| K220721 |
03/14/2022 |
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 |
Fresenius Medical Care Renal Therapies Group, LLC |
| K150708 |
03/19/2015 |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K181108 |
04/27/2018 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K201207 |
05/05/2020 |
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 |
Fresenius Medical Care Renal Therapies Group, LLC |
| K141281 |
05/16/2014 |
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K191407 |
05/28/2019 |
Novalung System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K191474 |
06/04/2019 |
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) |
Fresenius Medical Care Renal Therapies Group, LLC |
| K171652 |
06/05/2017 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K131908 |
06/26/2013 |
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K172238 |
07/26/2017 |
CAREline Airless Hemodialysis Blood Tubing Sets |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192017 |
07/29/2019 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K222318 |
08/02/2022 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
| K212522 |
08/11/2021 |
Lilliput APD System |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192209 |
08/14/2019 |
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K212620 |
08/18/2021 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
| K182367 |
08/31/2018 |
DIASAFEplusUS |
Fresenius Medical Care Renal Therapies Group, LLC |
| K192707 |
09/27/2019 |
Optiflux F180NR Dialyzer |
Fresenius Medical Care Renal Therapies Group, LLC |
| K162716 |
09/29/2016 |
bibag |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K203062 |
10/09/2020 |
Optiflux Series of Dialyzers F160NR, F180NR, F200NR |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173363 |
10/26/2017 |
Cycler Drain Bag Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173593 |
11/21/2017 |
stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173651 |
11/28/2017 |
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K153449 |
11/30/2015 |
2008K2 Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K173718 |
12/05/2017 |
Liberty Cycler Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K213992 |
12/21/2021 |
CombiSet Hemodialysis Blood Tubing Set |
Fresenius Medical Care Renal Therapies Group, LLC |
| K173972 |
12/29/2017 |
2008T BlueStar Hemodialysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
| K141145 |
05/02/2014 |
LIBERTY PDX CYCLER |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
| K222952 |
09/27/2022 |
2008T BlueStar Hemodailysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
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