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510(k) Data Aggregation

    K Number
    K014075
    Device Name
    BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    2002-03-07

    (86 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BMC Coaxial Injectable Catheter is intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    Device Description

    BMC Coaxial Injectable Catheter

    AI/ML Overview

    I am sorry, but the provided text is a scanned FDA 510(k) clearance letter for a medical device and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth, or expert qualifications for AI/ML-based device evaluation.

    The letter only states that the "BMC Coaxial Injectable Catheter" has been found substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory information regarding marketing, classification, and general controls.

    Therefore, I cannot fulfill your request based on the provided input.

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