FDA 510(k) Applications Submitted by BARRY S SALL

FDA 510(k) Number Submission Date Device Name Applicant
K040082 01/15/2004 PORE-SI BONE GRAFT SUBSTITUTE APATECH LTD.
K030154 01/16/2003 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A.
K120185 01/23/2012 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR SORIN GROUP ITALIA S.R.L.
K020351 02/04/2002 D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR DIDECO S.P.A.
K010396 02/09/2001 C. NET 2100 CARDIONETICS, LTD.
K080351 02/11/2008 DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI DEXELA LTD
K050447 02/22/2005 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.R.L.
K100507 02/22/2010 XRES BLOOD COLLECTION RESERVOIR SORIN GROUP ITALIA S.R.L
K110782 03/21/2011 XVAC SORIN GROUP ITALIA S.R.L.
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.
K050890 04/08/2005 ECC.O SYSTEM DIDECO S.R.L.
K061031 04/14/2006 D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W SORIN GROUP ITALIA S.R.L.
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.
K121229 04/24/2012 INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY SORIN GROUP ITALIA S.R.L.
K081313 05/09/2008 SH14 HEMOCONCENTRATOR SORIN GROUP ITALIA S.R.L.
K051232 05/13/2005 D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER DIDECO S.R.L.
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.
K972001 05/30/1997 NICAS(TM) ELECTRODE NI MEDICAL
K061527 06/02/2006 CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING SORIN GROUP ITALIA S.R.L.
K101586 06/07/2010 XTRA AUTOTRANSFUSION SYSTEM SORIN GROUP ITALIA S.R.L.
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.
K072091 07/30/2007 D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR SORIN GROUP ITALIA S.R.L.
K112245 08/04/2011 XTRA SORIN GROUP ITALIA S.R.L
K953835 08/16/1995 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR DIDECO S.R.L.
K072308 08/17/2007 D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED SORIN GROUP ITALIA S.R.L.
K112525 08/31/2011 D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS PAREXELINTERNATIONAL
K092895 09/21/2009 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA S.R.L.
K052717 09/29/2005 D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER DIDECO S.R.L.
K083021 10/09/2008 APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA S.R.L.
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.
K063255 10/27/2006 D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED SORIN GROUP ITALIA S.R.L
K103202 11/01/2010 PREASSEMBLED SURGICAL WASH SET SORIN GROUP ITALIA S.R.L.
K093601 11/20/2009 AF 840 PH.I.S.I.O. ARTERIAL FILTER SORIN GROUP ITALIA S.R.L.
K033722 11/26/2003 APAPORE BONE GRAFT SUBSTITUTE APATECH LTD.
K033714 11/26/2003 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING DIDECO S.P.A.
K043323 12/02/2004 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DIDECO S.R.L.
K984322 12/03/1998 DIDECO D920, LILLIPUT 1 TWIN RESERVOIR DIDECO S.P.A.
K073380 12/03/2007 SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI SORIN GROUP ITALIA S.R.L.
K113626 12/08/2011 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SORIN GROUP ITALIA S.R.L.
K033987 12/23/2003 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS DIDECO S.P.A.
K093986 12/24/2009 AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS SORIN GROUP ITALIA S.R.L.
K131553 05/30/2013 XTRA SORIN GROUP DEUTSCHLAND GMBH
K014080 12/11/2001 APEX ADULT HOLLOWE FIBER OXYGENATOR DIDECO S.P.A.
K093706 12/01/2009 PROXISCAN MODEL 101 HYBRIDYNE IMAGING TECHNOLOGIES, INC


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