Gambro Healthcare - FDA 510(k) Cleared Devices

Cleared Oct 26, 2000

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

K994390 · MSF

Gastroenterology & Urology · 303d

Cleared Apr 21, 1999

COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS

K982413 · KDI

Gastroenterology & Urology · 282d

Cleared Mar 26, 1999

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

K982414 · KDI

Gastroenterology & Urology · 256d

Cleared Feb 24, 1999

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...

K980386 · KDI

Gastroenterology & Urology · 387d

Cleared Nov 04, 1998

COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

K982760 · KDI

Gastroenterology & Urology · 90d

Cleared Sep 23, 1998

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H

K974899 · FIP

Gastroenterology & Urology · 267d

Cleared Aug 11, 1998

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

K981681 · KDI

Gastroenterology & Urology · 90d

Cleared May 18, 1998

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

K981085 · FIP

Gastroenterology & Urology · 54d

Cleared Sep 26, 1997

COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET

K970253 · KDI

Gastroenterology & Urology · 247d

Cleared Sep 20, 1996

COBE CENTRYSYSTEM 700 HG HEMODIALYZER

K962427 · KDI

Gastroenterology & Urology · 88d

Cleared Aug 28, 1996

REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE...

K954623 · FKT

Gastroenterology & Urology · 328d