FDA 510(k) Applications Submitted by Baxter Healthcare Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K073571 12/20/2007 TRICOS T RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORPORATION
K201867 07/07/2020 Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation
K181225 05/08/2018 ALTAPORE Baxter Healthcare Corporation
K211035 04/07/2021 U9000 Plus Ultrafilter Baxter Healthcare Corporation
K193482 12/17/2019 PrisMax System Version 3 Baxter Healthcare Corporation
K181306 05/17/2018 Actifuse Flow Baxter Healthcare Corporation
K062079 07/21/2006 XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION
K053539 12/20/2005 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORPORATION
K150860 04/01/2015 Nitroglycerin Sets with DUO-VENT Spike BAXTER HEALTHCARE CORPORATION
K211125 04/15/2021 Novum IQ Syringe Pump Baxter Healthcare Corporation
K173084 09/29/2017 Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation
K083778 12/19/2008 XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION
K212216 07/16/2021 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set Baxter Healthcare Corporation
K192366 08/30/2019 Intravascular Extension Sets and Accessories Baxter Healthcare Corporation
K142600 09/15/2014 VIAL-MATE Adaptor BAXTER HEALTHCARE CORPORATION
K153158 11/02/2015 Solution Administration Sets with 0.2 Micron Filter BAXTER HEALTHCARE CORPORATION
K210335 02/05/2021 Blood Administration Set Baxter Healthcare Corporation
K220558 02/28/2022 Blood Administration Sets Baxter Healthcare Corporation
K180739 03/22/2018 Clearlink System Solution Set Baxter Healthcare Corporation
K211649 05/28/2021 PCEA Syringe Set Baxter Healthcare Corporation
K212262 07/20/2021 PCA Syringe Sets Baxter Healthcare Corporation
K203609 12/10/2020 Intravascular Administration Sets Baxter Healthcare Corporation
K220417 02/14/2022 Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation
K222048 07/12/2022 Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation
K213639 11/18/2021 Revaclear 500, Revaclear 400, Revaclear 300 Baxter Healthcare Corporation
K172544 08/23/2017 IV Fat Emulsion Administration Sets Baxter Healthcare Corporation
K161808 07/01/2016 Solution Set with 1.2 Micron Air Eliminating Filter Baxter Healthcare Corporation
K041738 06/28/2004 BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) BAXTER HEALTHCARE CORPORATION
K232467 08/15/2023 CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation
DEN190042 09/16/2019 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation
K162887 10/17/2016 PrismaSATE Baxter Healthcare Corporation
K214016 12/22/2021 15L Cycler Drainage Bag Baxter Healthcare Corporation
K230022 01/04/2023 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library Baxter Healthcare Corporation
K230041 01/06/2023 Spectrum IQ Infusion System with Dose IQ Safety Software Baxter Healthcare Corporation
K210430 02/12/2021 Intravascular Extension Set Baxter Healthcare Corporation
K223175 10/11/2022 lntravascular Administration Sets with Stopcock and Manifold Baxter Healthcare Corporation
K211124 04/15/2021 Dose IQ Safety Software Baxter Healthcare Corporation
K090096 01/15/2009 ALL-IN-ONE CONTAINER BAXTER HEALTHCARE CORPORATION
K121634 06/04/2012 INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR BAXTER HEALTHCARE CORPORATION
K062457 08/23/2006 INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORPORATION
K112893 10/03/2011 CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS BAXTER HEALTHCARE CORPORATION
K200640 03/11/2020 ALTAPORE SHAPE Baxter Healthcare Corporation
K201464 06/02/2020 Altapore MIS Baxter Healthcare Corporation
K191513 06/07/2019 Altapore Shape Baxter Healthcare Corporation
K192363 08/30/2019 Altapore Baxter Healthcare Corporation
K171671 06/06/2017 Prismaflex System 8.10 Baxter Healthcare Corporation
K133801 12/13/2013 BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY BAXTER HEALTHCARE CORPORATION
K160007 01/04/2016 Paclitaxel Sets BAXTER HEALTHCARE CORPORATION
K161323 05/11/2016 Solution Set for Epidural Use BAXTER HEALTHCARE CORPORATION
K142011 07/24/2014 SOLUTION SET/EXTENSION SET BAXTER HEALTHCARE CORPORATION
K152129 07/31/2015 FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution BAXTER HEALTHCARE CORPORATION
K092318 08/04/2009 BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE BAXTER HEALTHCARE CORPORATION


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