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CORPAK MedSystems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2162-2017Class IICORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG TubFebruary 3, 2017
Z-2163-2017Class IICORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteraFebruary 3, 2017
Z-2161-2017Class IICORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PFebruary 3, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K142012FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORSNovember 20, 2014
K133599CORGRIPMarch 26, 2014
K131532ELECTROMAGNETIC TRANSMITTING STYLETAugust 12, 2013
K113351CORTRAK ENTERAL ACCESS DEVICEJanuary 10, 2012
K100365FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIVMay 20, 2010
K091637CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900September 29, 2009
K083776CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-SMarch 5, 2009
K083791CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-SMarch 4, 2009
K083786CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LBFebruary 20, 2009
K083121NEO MAPCATH SENSOR STYLETFebruary 11, 2009
K083210CORFLO ANTI IV ENTERAL FEEDING TUBEDecember 29, 2008
K990127CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)February 10, 1999
K840656ENTERNAL Y EXTENSION SET RECORDERApril 4, 1984
K831328NEONATAL NASOGASTRIC FEEDING TUBE-July 19, 1983
K821906CORPAK ENTERIC FEEDING TUBE W/GUIDE TIPJuly 13, 1982