MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMODIALYZER, MODEL RP610, RP AN 69

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C-DAK DUO-FLUX ARTIFICIAL KIDNEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX, MODEL 140H, 170H, 210H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX SYSTEM, VERSION 3.20

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TABLO CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FRESENIUS OPTIFLUX 200NR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALTRA FLUX 200 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INPERSOL CAPD BIOCAP ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology