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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