Medical Device Manufacturer · US , Tewksburt , MA

Nxstage Medical, Inc.

51 submissions · 51 cleared · Since 2001
51
Total
51
Cleared
0
Denied

Nxstage Medical, Inc. — FDA 510(k) Submissions

Nxstage Medical, Inc. has submitted 51 FDA 510(k) premarket notifications since 2001, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Dialysate Concentrate For Hemodialysis (liquid Or Powder), Subsystem, Proportioning, System, Dialysate Delivery, Single Patient, Ultrafiltration-controlled Nocturnal Dialysate Delivery System . Use the specialty filter in the sidebar to narrow results.

51 devices
1–25 of 51
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2024 184d
NxStage PureFlow Solution
K233213 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jan 2024 112d
VersiHD with GuideMe software
K230632 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 2023 157d
NxStage Cartridge Express with Speedswap
K183158 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 2019 267d
NxStage Connected Health System
K181991 · FKP System, Dialysate... · Gastroenterology & Urology
Sep 2018 62d
NxStage System One
K171331 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 2017 108d
NxStage System One Plus
K170469 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2017 82d
NxStage System One
K150472 · ODN Ultrafiltration-controlle... · Gastroenterology & Urology
Jun 2015 101d
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
K143313 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2015 121d
NXSTAGE SYSTEM ONE
K141752 · ODN Ultrafiltration-controlle... · Gastroenterology & Urology
Dec 2014 172d
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
K134019 · FIE Needle, Fistula · Gastroenterology & Urology
Sep 2014 255d
NXSTAGE EXPRESS FLUID WARMER
K140623 · FLA Monitor, Temperature,... · Gastroenterology & Urology
Jun 2014 97d
NXSTAGE SYSTEM ONE
K140526 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2014 76d
NXSTAGE PUREFLOW SL
K140571 · FKR Subsystem, Proportioning · Gastroenterology & Urology
May 2014 70d
NXSTAGE SYSTEM ONE WITH NXVIEW
K133547 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2014 104d
STREAMLINE EXPRESS
K132602 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 2014 168d
NXSTAGE 1.6M2 DIALYZER
K131050 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2013 256d
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · FKP System, Dialysate... · Gastroenterology & Urology
Oct 2013 119d
NXSTAGE DOSING CALCULATOR
K130460 · FKP System, Dialysate... · Gastroenterology & Urology
Jul 2013 139d
NXSTAGE SYSTEM ONE
K122051 · KDI Dialyzer, High... · Gastroenterology & Urology
Apr 2013 285d
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 2013 122d
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2012 437d
NXSTAGE PUREFLOW SL
K111174 · FKR Subsystem, Proportioning · Gastroenterology & Urology
Sep 2011 145d
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
K093069 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2010 388d
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Feb 2009 8d
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