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510(k) Data Aggregation

    K Number
    K252238
    Device Name
    CoroFlow Cardiovascular System
    Manufacturer
    Coroventis Research AB
    Date Cleared
    2025-10-24

    (99 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K201881,K183099,K092105
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 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.

    AI/ML Overview

    N/A

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