Dideco S.P.A.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTEROctober 20, 2005
K051232D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTEMay 20, 2005
K050890ECC.O SYSTEMMay 5, 2005
K050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATORMarch 8, 2005
K043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRFebruary 1, 2005
K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSMay 6, 2004
K033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOJanuary 13, 2004
K033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERSJanuary 8, 2004
K033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATINGDecember 11, 2003
K032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULTJuly 9, 2003
K031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATORMay 2, 2003
K030154IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRAMarch 31, 2003
K021732DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PENovember 4, 2002
K022450INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELLOctober 22, 2002
K020647DIDECO ELECTASeptember 5, 2002
K020997APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATORApril 4, 2002
K020351D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATORFebruary 26, 2002
K014080APEX ADULT HOLLOWE FIBER OXYGENATORJanuary 8, 2002
K013915D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTERDecember 27, 2001
K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOROctober 4, 2001