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510(k) Data Aggregation

    K Number
    K972110
    Device Name
    Cordis Endeavor Infusion Catheter
    Manufacturer
    CORDIS CORP.
    Date Cleared
    1997-08-14

    (70 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K980486,K954848
    Predicate For
    K063620
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.

    Device Description

    The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Cordis Endeavor Infusion Catheter and does not contain the specific information requested in the prompt. The document describes an administrative change to a previous substantial equivalence determination letter and discusses the general regulatory requirements for the device. It provides a summary of safety and effectiveness but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a device based on AI/ML.

    Therefore, I cannot extract the requested information from this document.

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