Nxstage Medical, Inc.

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K232803	NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)	KDI	2024-03-14	View
510(k)	K233213	NxStage PureFlow Solution	KPO	2024-01-18	View
510(k)	K230632	VersiHD with GuideMe software	KDI	2023-08-11	View
510(k)	K183158	NxStage Cartridge Express with Speedswap	KDI	2019-08-09	View
510(k)	K181991	NxStage Connected Health System	FKP	2018-09-26	View
510(k)	K171331	NxStage System One	KDI	2017-08-24	View
510(k)	K170469	NxStage System One Plus	KDI	2017-05-09	View
510(k)	K131050	NXSTAGE 1.6M2 DIALYZER	KDI	2013-12-27	View
510(k)	K131739	NXSTAGE CONNECTED HEALTH SYSTEM	FKP	2013-10-10	View
510(k)	K130460	NXSTAGE DOSING CALCULATOR	FKP	2013-07-11	View
510(k)	K122051	NXSTAGE SYSTEM ONE	KDI	2013-04-23	View
510(k)	K123395	NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS	KDI	2013-03-07	View
510(k)	K113023	STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER	KDI	2012-12-21	View
510(k)	K111174	NXSTAGE PUREFLOW SL	FKR	2011-09-19	View
510(k)	K093069	NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE	KDI	2010-10-23	View
510(k)	K090255	BLOOD TUBING SETS (STERILE FLUID PATH)	FJK	2009-02-10	View
510(k)	K080919	NXSTAGE PUREFLOW SL	FKR	2008-10-15	View
510(k)	K080807	BLOOD TUBING SETS (STERILE FLUID PATH)	FJK	2008-07-18	View
510(k)	K081043	LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT	KOC	2008-07-07	View
510(k)	K071263	NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500	KDI	2007-08-24	View