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510(k) Data Aggregation

    K Number
    K201881
    Device Name
    CoroFlow Cardiovascular System
    Date Cleared
    2020-11-13

    (129 days)

    Product Code
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coroventis Research AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases. CoroFlow is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display various physiological parameters based on the output from one or more measuring devices.
    Device Description
    CoroFlow Cardiovascular system is used to calculate, display and store physiological parameters based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box. Calculated parameters include physiological indices to assess coronary lesion severity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation (IMR, CFR). The system also provides novel indices based on the same raw pressure and temperature measurements (IMR_Corr, RRR, Absolute Flow/Resistance, dP/dt, Tau). CoroFlow™ is installed on a personal computer and receives measurement data wirelessly via the CoroHub™ Receiver. Information is displayed on the computer screen which can optionally be slaved to a monitor inside the coronary cathlab. Data can be stored on a local storage unit or transferred to a network location.
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