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510(k) Data Aggregation

    K Number
    K251832
    Device Name
    InZone IST Detachment System; IZDS Connecting Cable
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2025-10-17

    (123 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K212455
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InZone IST Detachment System is intended for use with all versions of Stryker Neurovascular embolization devices in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

    Device Description

    Stryker Neurovascular's InZone IST Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular embolization devices. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

    Stryker Neurovascular's IZDS Connecting Cable is a 180 cm cable intended for use with the InZone IST Detachment System in the detachment of monopolar embolization devices. The cable completes the connection between the InZone IST unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.

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