FDA 510(k) Applications Submitted by GARRY A COURTNEY

FDA 510(k) Number Submission Date Device Name Applicant
K140008 01/02/2014 VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corporation
K150536 03/03/2015 Terumo Circuit Tubing Terumo Cardiovascular Systems Corporation
K070839 03/27/2007 MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K020998 03/28/2002 SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X TERUMO CARDIOVASCULAR SYSTEMS CORP.
K073474 12/11/2007 CAPIOX CIRCUIT CONNECTORS TERUMO CORP.
K040023 01/07/2004 CAPIOX FLEXIBLE VENOUS RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K040210 01/30/2004 CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR TERUMO CORP.
K030449 02/11/2003 MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR TERUMO CORP.
K010443 02/14/2001 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K030505 02/19/2003 CAPIOX CARDIOTOMY RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K090698 03/17/2009 CAPIOX BUBBLE TRAP WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS
K080774 03/19/2008 CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) TERUMO CARDIOVASCULAR SYSTEMS CORP.
K021020 03/29/2002 TERUMO GAS FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP.
K151389 05/26/2015 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir Terumo Cardiovascular Systems Corporation
K071572 06/08/2007 CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER TERUMO CORP.
K991973 06/11/1999 CAPIOX SX10 HARDSHELL RESEVOIR TERUMO MEDICAL CORP.
K011804 06/11/2001 CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X TERUMO CARDIOVASCULAR SYSTEMS CORP.
K041697 06/22/2004 TERUMO CIRCUIT CONNECTORS Terumo Cardiovascular Systems Corporation
K022115 07/01/2002 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR TERUMO CORP.
K002026 07/03/2000 CAPIOX ARTERIAL FILTER TERUMO MEDICAL CORP.
K032128 07/10/2003 TERUMO AL8X ARTERIAL FILTER WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K012209 07/16/2001 CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X TERUMO CARDIOVASCULAR SYSTEMS CORP.
K002238 07/24/2000 CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K051997 07/25/2005 CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K132451 08/06/2013 SARNS SOFT-FLOW AORTIC CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP.
K052205 08/12/2005 CAPIOX AF125X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP.
K062381 08/15/2006 CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K092644 08/27/2009 TERUMO PRESSURE ISOLATOR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K992906 08/30/1999 COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT OLSON MEDICAL SALES, INC.
K132811 09/09/2013 SARNS SOFT-FLOW EXTENDED AORTIC CANNULA Terumo Cardiovascular Systems Corporation
K993060 09/13/1999 GAS FILTER OLSON MEDICAL SALES, INC.
K993062 09/13/1999 CHEST DRAINAGE TUBING OLSON MEDICAL SALES, INC.
K993189 09/23/1999 CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING TERUMO CORP.
K133151 10/17/2013 SARNS HIGH FLOW AORTIC ARCH CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP.
K013526 10/23/2001 CAPIOX RX HARDSHELL RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K013578 10/29/2001 PUMP TUBING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K003371 10/30/2000 PUMP TUBING WITH X-COATING TERUMO CORP.
K993772 11/08/1999 X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR TERUMO MEDICAL CORP.
K003604 11/21/2000 ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K033800 12/05/2003 CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems Corporation
K083747 12/17/2008 TERUMO PALL AL3X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP.
K130280 02/05/2013 CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR TERUMO Corporation
K130493 02/26/2013 CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR TERUMO Corporation
K172071 07/10/2017 Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) Terumo Cardiovascular Systems Corporation


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