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Gish Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
75
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTSeptember 18, 2009
K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTSeptember 18, 2009
K091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730August 4, 2009
K083131MEDOS HILITE RESERVOIR, MODEL: 4030July 30, 2009
K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTMay 15, 2009
K081947GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATINGFebruary 4, 2009
K082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATINGFebruary 4, 2009
K080708VISION HOLLOW FIBER OXYGENATOR WITH HA COATINGFebruary 2, 2009
K081838GISH VISION BLOOD CARDIOPLEGIA WITH HA COATINGJanuary 26, 2009
K081881GISH TUBING AND CONNECTORS WITH HA COATINGJanuary 23, 2009
K081054GISH ARTERIAL FILTER WITH HA COATINGJanuary 15, 2009
K051606GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATINGAugust 12, 2005
K050195V-BAG WITH GBS COATINGMarch 17, 2005
K040355VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATINGMarch 15, 2004
K030726GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATINGMay 30, 2003
K031300IBC FLOPUMP WITH GBS COATINGMay 14, 2003
K023833GISH ARTERIAL FILTER WITH GBS COATINGMarch 31, 2003
K023381VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATINGMarch 31, 2003
K030077GISH TUBING AND CONNECTORS WITH GBS COATINGMarch 14, 2003
K024065SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATINGMarch 5, 2003