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510(k) Data Aggregation

    K Number
    K241177
    Device Name
    React 71 Catheter
    Manufacturer
    Micro Therapeutics lnc. d/b/a ev3 Neurovascular
    Date Cleared
    2024-05-28

    (29 days)

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

    Micro Therapeutics lnc. d/b/a ev3 Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
    Device Description
    The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.
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