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510(k) Data Aggregation

    K Number
    K192625
    Device Name
    PG Pro Microcatheter
    Manufacturer
    MicroVention, Inc., A Terumo Group Company
    Date Cleared
    2019-11-21

    (59 days)

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

    MicroVention, Inc., A Terumo Group Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
    Device Description
    The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.
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