FDA 510(k) Applications Submitted by NxStage Medical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K183158 11/15/2018 NxStage Cartridge Express with Speedswap NxStage Medical, Inc.
K230632 03/07/2023 VersiHD with GuideMe software NxStage Medical, Inc.
K001283 04/21/2000 LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC.
K011269 04/26/2001 LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR NXSTAGE MEDICAL, INC.
K012832 08/23/2001 COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 NXSTAGE MEDICAL, INC.
K013655 11/06/2001 NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 NXSTAGE MEDICAL, INC.
K012510 08/06/2001 MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC.
K134019 12/30/2013 MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO NXSTAGE MEDICAL, INC.
K122051 07/12/2012 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K140571 03/06/2014 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC.
K150472 02/23/2015 NxStage System One NXSTAGE MEDICAL, INC.
K140526 03/04/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K140623 03/11/2014 NXSTAGE EXPRESS FLUID WARMER NXSTAGE MEDICAL, INC.
K081043 04/14/2008 LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT NXSTAGE MEDICAL, INC.
K111174 04/27/2011 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC.
K131739 06/13/2013 NXSTAGE CONNECTED HEALTH SYSTEM NXSTAGE MEDICAL, INC.
K141752 06/30/2014 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K132602 08/20/2013 STREAMLINE EXPRESS NXSTAGE MEDICAL, INC.
K113023 10/11/2011 STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER NXSTAGE MEDICAL, INC.
K123395 11/05/2012 NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC.
K133547 11/19/2013 NXSTAGE SYSTEM ONE WITH NXVIEW NXSTAGE MEDICAL, INC.
K090255 02/02/2009 BLOOD TUBING SETS (STERILE FLUID PATH) NXSTAGE MEDICAL, INC.
K080807 03/21/2008 BLOOD TUBING SETS (STERILE FLUID PATH) NXSTAGE MEDICAL, INC.
K080919 04/01/2008 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC.
K093069 09/30/2009 NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE NXSTAGE MEDICAL, INC.
K130460 02/22/2013 NXSTAGE DOSING CALCULATOR NXSTAGE MEDICAL, INC.
K131050 04/15/2013 NXSTAGE 1.6M2 DIALYZER NXSTAGE MEDICAL, INC.
K040074 01/14/2004 ONEVIEW INTERFACE NXSTAGE MEDICAL, INC.
K060296 02/06/2006 NXSTAGE DIALYSATE PREPARATION MODULE NXSTAGE MEDICAL, INC.
K030470 02/12/2003 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K050525 03/02/2005 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K040696 03/17/2004 MODIFICATION TO NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K020858 03/18/2002 NXSTAGE THERAPY SYSTEM NXSTAGE MEDICAL, INC.
K050727 03/21/2005 MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC.
K071263 05/07/2007 NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 NXSTAGE MEDICAL, INC.
K041424 05/28/2004 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC.
K061837 06/29/2006 NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC.
K032356 07/30/2003 NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC.
K042045 07/30/2004 NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC.
K022913 09/03/2002 NXSTAGE PREMIXED DIALYSATE NXSTAGE MEDICAL, INC.
K033386 10/23/2003 NXSTAGE PUREFLOW SOLUTION NXSTAGE MEDICAL, INC.
K053286 11/25/2005 MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC.
K043436 12/13/2004 NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 NXSTAGE MEDICAL, INC.
K014152 12/18/2001 NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC.
K171331 05/08/2017 NxStage System One NxStage Medical, Inc.
K143313 11/19/2014 NxStage Therapeutic Plasma Exchange (TPE) Cartridge NxStage Medical, Inc.


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