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Gambro Healthcare

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K994390 GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERMSF2000-10-26 View
510(k) K990039 GAMBRO DQM 200LFP2000-01-27 View
510(k) K982413 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSKDI1999-04-21 View
510(k) K982414 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSKDI1999-03-26 View
510(k) K980386 HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)KDI1999-02-24 View
510(k) K982760 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SETKDI1998-11-04 View
510(k) K982818 HOSPAL TIPSTOPKMF1998-10-21 View
510(k) K974899 GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO HFIP1998-09-23 View
510(k) K981681 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)KDI1998-08-11 View
510(k) K981085 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEMFIP1998-05-18 View
510(k) K970253 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SETKDI1997-09-26 View
510(k) K962427 COBE CENTRYSYSTEM 700 HG HEMODIALYZERKDI1996-09-20 View
510(k) K954623 REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)FKT1996-08-28 View
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