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510(k) Data Aggregation

    K Number
    K090917
    Device Name
    SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
    Manufacturer
    BAXA CORP.
    Date Cleared
    2010-02-19

    (324 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

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

    The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the SureConnect® Closed Drug Reconstitution and Transfer System, indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.

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