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510(k) Data Aggregation

    K Number
    K180023
    Device Name
    WIRION
    Manufacturer
    Gardia Medical Ltd.
    Date Cleared
    2018-03-21

    (77 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gardia Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
    Device Description
    WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.
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    K Number
    K143570
    Device Name
    WIRION
    Manufacturer
    GARDIA MEDICAL
    Date Cleared
    2015-06-04

    (169 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    GARDIA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.
    Device Description
    WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.
    Ask a Question

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