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510(k) Data Aggregation

    K Number
    K102147
    Device Name
    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
    Manufacturer
    CARDIOQUIP LLP
    Date Cleared
    2010-11-19

    (112 days)

    Product Code
    DWC
    Regulation Number
    870.4250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOQUIP LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text only contains an FDA 510(k) clearance letter for the CardioQuip Modular Cooler-Heater (MCH). This document does not contain any information about acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given text.

    The document primarily focuses on:

    • Confirming the substantial equivalence of the CardioQuip MCH to a legally marketed predicate device.
    • Outlining regulatory requirements and guidance for the manufacturer (CardioQuip, LLP).
    • Stating the intended "Indications For Use" for the CardioQuip MCH.
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