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510(k) Data Aggregation

    K Number
    K971281
    Device Name
    RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
    Manufacturer
    MEDCOMP
    Date Cleared
    1997-10-09

    (185 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K043446
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (Raulerson® One-Step Guidewire Insertion Bulb Needle) and primarily discusses regulatory compliance and marketing authorization. It does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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