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510(k) Data Aggregation

    K Number
    K251722

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (184 days)

    Product Code
    Regulation Number
    880.5440
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ProSeal™ Transfer Injector is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

    Device Description

    The ProSeal™ Transfer Injector is a fully encapsulated syringe unit that that supports the use of ProSeal™ Injector Plus (K240171) in hazardous drug handling. The integrated ProSeal™ Injector Plus which incorporates a female connector, is permanently attached onto the syringe body, thus preventing accidental disconnections. It houses a shielded needle to prevent the risk of accidental needle sticks. All ProSeal™ Transfer Injector subcomponents are not made with DEHP*, latex nor BPA and substantiated for safe use with antineoplastic and hazardous drugs.

    AI/ML Overview

    N/A

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