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510(k) Data Aggregation

    K Number
    K090114

    Validate with FDA (Live)

    Device Name
    MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
    Manufacturer
    Oscor Inc.
    Date Cleared
    2009-06-04

    (134 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K101497
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device (Introducer Set). It does not contain any information about acceptance criteria, study designs, or performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information.

    The letter simply states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It does not include any scientific study data or details about device performance metrics beyond its intended use.

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