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510(k) Data Aggregation

    K Number
    K150107
    Device Name
    Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
    Manufacturer
    MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR
    Date Cleared
    2015-07-29

    (190 days)

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

    MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.
    Device Description
    The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.
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