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Terumo Cardiovascular Systems Corporation

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories6
Latest FDA decision2024-04-25
TypeNumberDevice NameCodeDateActions
510(k) K234065 CDI OneView Monitoring SystemDRY2024-04-25 View
510(k) K221895 Terumo Advanced Perfusion System 1DTQ2023-04-18 View
510(k) K200091 Capiox iCP Centrifugal PumpKFM2021-11-18 View
510(k) K182110 CDI Blood Parameter Monitoring System 550DRY2018-11-02 View
510(k) K180950 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)DTZ2018-06-22 View
510(k) K172071 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)DTZ2018-03-29 View
510(k) K172220 Advanced Perfusion System 1DTQ2017-08-17 View
510(k) K163531 Advanced Perfusion System 1DTQ2017-06-07 View
510(k) K162843 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1DWB2016-11-17 View
510(k) K160206 VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI2016-04-21 View
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