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510(k) Data Aggregation

    K Number
    K252514

    Validate with FDA (Live)

    Device Name
    EVAC-MRI
    Manufacturer
    Date Cleared
    2025-11-05

    (86 days)

    Product Code
    Regulation Number
    882.5550
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Phasor EVAC-MRI is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Phasor EVAC-MRI system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Phasor EVAC–MRI system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

    Device Description

    Phasor EVAC-MRI™ subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Phasor EVAC-MRI™ system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Phasor EVAC-MRI™ system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Phasor EVAC-MRI™ system saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

    AI/ML Overview

    N/A

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