Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terumo Cardiovascular Systems Corporation

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

Total Devices10
Categories6
Latest Approval2024-04-25
TypeNumberDevice NameCodeDate
510(k) K234065 CDI OneView Monitoring System DRY 2024-04-25 View
510(k) K221895 Terumo Advanced Perfusion System 1 DTQ 2023-04-18 View
510(k) K200091 Capiox iCP Centrifugal Pump KFM 2021-11-18 View
510(k) K182110 CDI Blood Parameter Monitoring System 550 DRY 2018-11-02 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) DTZ 2018-06-22 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) DTZ 2018-03-29 View
510(k) K172220 Advanced Perfusion System 1 DTQ 2017-08-17 View
510(k) K163531 Advanced Perfusion System 1 DTQ 2017-06-07 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 1 DWB 2016-11-17 View
510(k) K160206 VirtuoSaph Plus Endoscopic Vessel Harvesting System GEI 2016-04-21 View