FDA 510(k) Applications Submitted by Denise Oppermann

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
K120017 01/03/2012 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMERICA
K220281 02/01/2022 multiFiltratePRO System Fresenius Medical Care Renal Therapies Group, LLC
K120505 02/21/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K190459 02/26/2019 Hemoflow F3 and F4 Dialyzers Fresenius Medical Care Renal Therapies Group, LLC
K230632 03/07/2023 VersiHD with GuideMe software NxStage Medical, Inc.
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
K120823 03/19/2012 BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
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
K121341 05/03/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMERICA
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
K121599 06/01/2012 CRIT-LINE CLIP (CLIC) FRESENIUS MEDICAL CARE-NORTH AMERICA
K131611 06/03/2013 FRESENIUS DRY ACID DISSOLUTION UNITS FRESENIUS MEDICAL CARE NORTH AMERICA
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
K111639 06/13/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE
K131908 06/26/2013 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
K141997 07/23/2014 CRIT-LINE IV SYSTEM FRESENIUS MEDICAL CARE
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
K152367 08/21/2015 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA
K182367 08/31/2018 DIASAFEplusUS Fresenius Medical Care Renal Therapies Group, LLC
K162488 09/07/2016 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA
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
K152953 10/07/2015 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE NORTH AMERICA
K203062 10/09/2020 Optiflux Series of Dialyzers F160NR, F180NR, F200NR Fresenius Medical Care Renal Therapies Group, LLC
K192928 10/17/2019 Optiflux Enexa F500 Dialyzer Fresenius Medical Care Reanal Therapies Group LLC
K123262 10/18/2012 OPTIFLUX ULTRA DIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA
K173363 10/26/2017 Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC
K213507 11/01/2021 AquaA Fresenius Medical Care Rental Therapies Group, LLC
K113427 11/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA
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
K123630 11/23/2012 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
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
K124024 12/28/2012 APD LUER-LOCK ADAPTER FRESENSIUS MEDICAL CARE NORTH AMERICA
K124035 12/28/2012 2008K@HOME HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA
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
K133299 10/25/2013 ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER


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