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510(k) Data Aggregation

    K Number
    K243577
    Device Name
    Radical the Dude 8F Guide Catheter
    Manufacturer
    Maduro Medical, Inc.
    Date Cleared
    2025-01-14

    (56 days)

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

    Maduro Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
    Device Description
    The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
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    K Number
    K231393
    Device Name
    Radical the Dude 7F Guide Catheter
    Manufacturer
    Maduro Medical, Inc.
    Date Cleared
    2023-11-30

    (202 days)

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

    Maduro Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radical the Dude 7F Guide Catheter is indicated for the intravascular catheters into the peripheral, coronary, and neuro vasculature.
    Device Description
    The Radical the Dude 7F Guide Catheter (Dude 7F Catheter) is a 7 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 7F Catheter has a usable length between 95 cm and 115 cm, and an outer diameter (OD) size designation of 7 Fr. The Dude 7F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 7F Catheter has a hydrophilic coating. The Dude 7F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
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