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510(k) Data Aggregation

    K Number
    K130633
    Device Name
    INTRODUCER SETS, MODEL ADELANTE RADIAL
    Manufacturer
    Oscor Inc.
    Date Cleared
    2014-02-13

    (339 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INTRODUCER SETS, MODEL ADELANTE RADIAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Adelante® Radial Introducer Set is indicated for the introduction of diagnostic and therapeutic catheters into the human vasculature. Do not use this device for neural placements.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Adelante® Radial Introducer Set." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    The letter approves the device based on its substantial equivalence to predicate devices already on the market but does not detail the specific performance metrics or studies that established this equivalence. It's a regulatory approval, not a technical performance report.

    Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory communication.

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