FDA 510(k) Applications Submitted by TERUMO CARDIOVASCULAR SYSTEMS CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K080034 01/07/2008 THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 TERUMO CARDIOVASCULAR SYSTEMS CORP.
K090878 03/31/2009 MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) TERUMO CARDIOVASCULAR SYSTEMS CORP.
K092789 09/10/2009 VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP.
K062597 09/01/2006 TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP.
K063618 12/05/2006 TENDERFLOW PERIATRIC ARTERIAL CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP.
K083834 12/23/2008 TERUMO PALL AL6X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP.
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.
K040023 01/07/2004 CAPIOX FLEXIBLE VENOUS RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS 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.
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.
K011804 06/11/2001 CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X TERUMO CARDIOVASCULAR SYSTEMS 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.
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.
K003604 11/21/2000 ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K083747 12/17/2008 TERUMO PALL AL3X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP.
K082321 08/13/2008 TERUMO ROCSAFE HYBRID PERFUSION SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP.
K153140 10/30/2015 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP.
K083194 10/29/2008 VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 TERUMO CARDIOVASCULAR SYSTEMS CORP.
K083301 11/10/2008 X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS TERUMO CARDIOVASCULAR SYSTEMS CORP.
K023056 09/13/2002 CIRCUIT TUBINGS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP.
K123039 09/28/2012 CDI BLOOD PARAMETER MONITORING SYSTEM 500 TERUMO CARDIOVASCULAR SYSTEMS CORP.
K133658 11/27/2013 CDI BLOOD PARAMETER MONITORING SYSTEM 500 TERUMO CARDIOVASCULAR SYSTEMS CORP.
K031891 06/13/2003 VIRTUOSAPH TERUMO CARDIOVASCULAR SYSTEMS CORP.
K131041 04/15/2013 ADVANCED PERFUSION SYSTEM 1 TERUMO CARDIOVASCULAR SYSTEMS CORP.
K071521 06/04/2007 TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP.
K022947 09/05/2002 ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH TERUMO CARDIOVASCULAR SYSTEMS CORP.
K112587 09/06/2011 ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, TERUMO CARDIOVASCULAR SYSTEMS CORP.
K113214 10/31/2011 TLINK DATA MANAGEMENT SYSTEM (DMS) TERUMO CARDIOVASCULAR SYSTEMS CORP.
K020967 03/25/2002 TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP.
K130333 02/11/2013 CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP.
K130359 02/13/2013 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA TERUMO CARDIOVASCULAR SYSTEMS CORP.


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