FDA 510(k) Applications Submitted by DIDECO S.P.A.

FDA 510(k) Number Submission Date Device Name Applicant
K030154 01/16/2003 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A.
K020351 02/04/2002 D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR DIDECO S.P.A.
K020997 03/28/2002 APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.P.A.
K001021 03/30/2000 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 DIDECO S.P.A.
K031223 04/18/2003 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR DIDECO S.P.A.
K041061 04/23/2004 D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS DIDECO S.P.A.
K971877 05/21/1997 LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR DIDECO S.P.A.
K991737 05/21/1999 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR DIDECO S.P.A.
K001602 05/24/2000 DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) DIDECO S.P.A.
K021732 05/24/2002 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT DIDECO S.P.A.
K032040 07/01/2003 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A.
K022450 07/26/2002 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY DIDECO S.P.A.
K033323 10/15/2003 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING DIDECO S.P.A.
K033714 11/26/2003 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING DIDECO S.P.A.
K984322 12/03/1998 DIDECO D920, LILLIPUT 1 TWIN RESERVOIR DIDECO S.P.A.
K033987 12/23/2003 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS DIDECO S.P.A.
K014080 12/11/2001 APEX ADULT HOLLOWE FIBER OXYGENATOR DIDECO S.P.A.
K992599 08/03/1999 DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR DIDECO S.P.A.
K980600 02/17/1998 D903 AVANT ADULT HOLLOW FIBER OXYGENATOR DIDECO S.P.A.
K020647 02/28/2002 DIDECO ELECTA DIDECO S.P.A.
K982650 07/30/1998 AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) DIDECO S.P.A.
K013915 11/27/2001 D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER DIDECO S.P.A.


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