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510(k) Data Aggregation

    K Number
    K253652

    Validate with FDA (Live)

    Device Name
    Genie MAX Large Bore Introducer Sheath
    Manufacturer
    Cultiv8 1, LLC
    Date Cleared
    2026-01-22

    (63 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K160254
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cultiv8 Genie MAX is intended to be inserted into the vasculature to provide a conduit for introducing intravascular devices while providing a hemostatic seal to minimize blood loss.

    Device Description

    The Genie MAX is a large bore introducer sheath system used for providing a conduit for introduction of intravascular devices while providing a hemostatic seal. The system includes an introducer sheath, protector, dilator and a 3cc syringe.

    AI/ML Overview

    N/A

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