FDA 510(k) Applications Submitted by Terumo Cardiovascular Systems Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K180950 04/11/2018 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
K162843 10/11/2016 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation
K153376 11/23/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation
K163531 12/16/2016 Advanced Perfusion System 1 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
K172220 07/24/2017 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation
K182110 08/06/2018 CDI Blood Parameter Monitoring System 550 Terumo Cardiovascular Systems Corporation
K140774 03/28/2014 TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR Terumo Cardiovascular Systems Corporation
K221895 06/30/2022 Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation
K093992 12/24/2009 TERUMO LAUER LOCK ADAPTER Terumo Cardiovascular Systems Corporation
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
K151389 05/26/2015 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir Terumo Cardiovascular Systems Corporation
K041697 06/22/2004 TERUMO CIRCUIT CONNECTORS Terumo Cardiovascular Systems Corporation
K132811 09/09/2013 SARNS SOFT-FLOW EXTENDED AORTIC CANNULA Terumo Cardiovascular Systems Corporation
K033800 12/05/2003 CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems 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
K151791 07/01/2015 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
K200091 01/16/2020 Capiox iCP Centrifugal Pump Terumo Cardiovascular Systems Corporation
K151349 05/20/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation
K131618 06/03/2013 LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST Terumo Cardiovascular Systems Corporation
K150542 03/03/2015 Terumo Pump Tubing TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
K022857 08/28/2002 PUMP TUBING WITH X-COATING Terumo Cardiovascular Systems Corporation
K022918 09/04/2002 ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corporation
K121209 04/20/2012 TERUMO PALL AL20X ARTERIAL FILTER Terumo Cardiovascular Systems Corporation
K142500 09/05/2014 One Way Soft Valve Terumo Cardiovascular Systems Corporation
K160206 01/28/2016 VirtuoSaph Plus Endoscopic Vessel Harvesting System Terumo Cardiovascular Systems Corporation
K153213 11/05/2015 Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Cardiovascular Systems Corporation
K153143 10/30/2015 Capiox Advance Hardshell Reservoir Terumo Cardiovascular Systems Corporation


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