Nxstage Medical, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 15, 2008

NXSTAGE PUREFLOW SL

K080919 · FKR

Gastroenterology & Urology · 197d

Cleared Jul 18, 2008

BLOOD TUBING SETS (STERILE FLUID PATH)

K080807 · FJK

Gastroenterology & Urology · 119d

Cleared Jul 07, 2008

LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT

K081043 · KOC

Gastroenterology & Urology · 84d

Cleared Aug 24, 2007

NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500

K071263 · KDI

Gastroenterology & Urology · 109d

Cleared Jul 31, 2006

NXSTAGE CARTRIDGE EXPRESS

K061837 · KDI

Gastroenterology & Urology · 32d

Cleared Mar 31, 2006

NXSTAGE DIALYSATE PREPARATION MODULE

K060296 · FKR

Gastroenterology & Urology · 53d

Cleared Dec 22, 2005

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

K053286 · KPO

Gastroenterology & Urology · 27d

Cleared Jun 24, 2005

NXSTAGE SYSTEM ONE

K050525 · KDI

Gastroenterology & Urology · 114d

Cleared Jun 13, 2005

MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS

K050727 · KDI

Gastroenterology & Urology · 84d

Cleared Mar 17, 2005

NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269

K043436 · FKR

Gastroenterology & Urology · 94d

Cleared Nov 24, 2004

NX STAGE WATER PURIFICATION SYSTEM

K042089 · FIP

Gastroenterology & Urology · 113d

Cleared Aug 27, 2004

NXSTAGE PUREFLOW-B SOLUTION

K042045 · KPO

Gastroenterology & Urology · 28d

Cleared Jul 02, 2004

NXSTAGE SYSTEM ONE

K041424 · KDI

Gastroenterology & Urology · 35d

Cleared May 26, 2004

MODIFICATION TO NXSTAGE SYSTEM ONE

K040696 · KDI

Gastroenterology & Urology · 70d

Cleared Apr 08, 2004

ONEVIEW INTERFACE

K040074 · FKP

Gastroenterology & Urology · 85d

Cleared Nov 26, 2003

NXSTAGE PUREFLOW SOLUTION

K033386 · KPO

Gastroenterology & Urology · 34d

Cleared Oct 28, 2003

NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS

K032356 · KDI

Gastroenterology & Urology · 90d

Cleared Jul 07, 2003

NXSTAGE SYSTEM ONE

K030470 · FII

Gastroenterology & Urology · 145d

Cleared Dec 11, 2002

NXSTAGE CARTRIDGE EXPRESS

K014152 · KDI

Gastroenterology & Urology · 358d

Cleared Oct 21, 2002

NXSTAGE PREMIXED DIALYSATE

K022913 · KPO

Gastroenterology & Urology · 48d

Cleared Apr 17, 2002

NXSTAGE THERAPY SYSTEM

K020858 · KDI

Gastroenterology & Urology · 30d

Cleared Mar 04, 2002

LIFEMATE MLA MULTI-LINE ADAPTOR

K011269 · KDI

Gastroenterology & Urology · 312d

Cleared Feb 04, 2002

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

K013655 · KPO

Gastroenterology & Urology · 90d

Cleared Oct 19, 2001

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

K012510 · KDI

Gastroenterology & Urology · 74d

Cleared Jan 17, 2001

LIFEMATE HEMOFILTRATION SYSTEM

K001283 · KDI

Gastroenterology & Urology · 271d