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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K191551
    Why did this record match?
    Device Name :

    Radical the Dude 7F Guide Catheter

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The document provided is a 510(k) Summary for the Radical the Dude 7F Guide Catheter. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. This document does NOT describe the acceptance criteria and study for an AI/ML powered device.

    The Radical the Dude 7F Guide Catheter is a medical device, specifically a guide catheter, and the submitted information pertains to its regulatory clearance as a physical medical device, not an AI/ML software device. As such, the information requested regarding AI/ML device performance (like test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable or present in this document.

    The document mainly focuses on:

    • Bench Testing: Mechanical and material property tests to ensure the device meets engineering specifications and is safe for its intended use.
    • Biocompatibility Testing: To ensure the materials used in the device are safe for contact with the human body.
    • Sterilization: Validation of the sterilization process.
    • Shelf Life and Packaging: Testing to ensure the device maintains its integrity over time.

    Therefore, I cannot provide the requested information for an AI/ML device based on this submission.

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