FDA 510(k) Applications Submitted by Sorin Group Italia S.R.L.

FDA 510(k) Number Submission Date Device Name Applicant
K092315 07/30/2009 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR SORIN GROUP ITALIA S.R.L.
K120185 01/23/2012 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR SORIN GROUP ITALIA S.R.L.
K110782 03/21/2011 XVAC SORIN GROUP ITALIA 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.
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.
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.
K072091 07/30/2007 D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR SORIN GROUP ITALIA 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.
K092895 09/21/2009 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA 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.
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.
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.
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.
K150489 02/25/2015 EOS PMP, EOS PMP Integrated SORIN GROUP ITALIA S.R.L.
K200612 03/09/2020 R501 aortic root cannula without vent line, R502 aortic root cannula with vent line Sorin Group Italia S.r.l.
K190650 03/13/2019 Revolution Centrifugal Blood Pump SORIN GROUP ITALIA S.R.L.
K200683 03/16/2020 INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoi Sorin Group Italia S.R.L.
K190690 03/18/2019 INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir SORIN GROUP ITALIA S.R.L.
K151713 06/25/2015 LILLIPUP PMP, LILLIPUT PMP INTEGRATED SORIN GROUP ITALIA S.R.L.
K223361 11/03/2022 BMR 1900 PHISIO Sorin Group Italia S.R.L.
K180411 02/15/2018 MEMO 4D Sorin Group Italia S.r.l.
K130209 01/29/2013 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED SORIN GROUP ITALIA S.R.L.
K130433 02/21/2013 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE SORIN GROUP ITALIA S.R.L.
K131103 04/19/2013 XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR SORIN GROUP ITALIA S.R.L.
K121536 05/24/2012 INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR SORIN GROUP ITALIA S.R.L.
K121909 06/29/2012 INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR SORIN GROUP ITALIA S.R.L.
K122254 07/27/2012 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SORIN GROUP ITALIA S.R.L.
K122844 09/17/2012 INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR SORIN GROUP ITALIA S.R.L.
K112771 09/23/2011 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG SORIN GROUP ITALIA S.R.L.


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