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Gambro Renal Products Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
37
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0490-2015Class IIPolyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux RevaclNovember 5, 2014
Z-0489-2015Class IIPolyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿November 5, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITMarch 26, 2014
K131516PRISMAFLEX SYSTEM 7.10January 3, 2014
K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERMay 2, 2013
K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)December 14, 2012
K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYMay 25, 2012
K110823PRISMAFLEXJune 17, 2011
K103832PHOENIX HEMODIALYSIS DELIVERY SYSTEMMay 20, 2011
K100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-132December 21, 2010
K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520November 3, 2010
K093608GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 HJuly 29, 2010
K080519PRISMAFLEX M150 SETJune 13, 2008
K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYFebruary 4, 2008
K070414GAMBRO CARTRIDGE BLOOD SETSOctober 12, 2007
K072232GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALLSeptember 7, 2007
K063183PRISMA M10 PRE SETFebruary 15, 2007
K063290GAMBRO QUICKSET BLOODLINESJanuary 30, 2007
K062090PRISMA SYSTEM R03.10AOctober 18, 2006
K060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USEApril 24, 2006
K051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6HDecember 9, 2005
K052253MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSISNovember 2, 2005