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510(k) Data Aggregation

    K Number
    K951927
    Device Name
    COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
    Manufacturer
    CSEN LTD.
    Date Cleared
    1997-05-30

    (767 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K042488
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Combined End Multilateral Holes (CEMLH) Epidural Catheter

    AI/ML Overview

    This document does not contain the detailed technical information required to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is a letter from the FDA regarding a 510(k) premarket notification for an epidural catheter, stating that the device has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information, as the input document focuses on regulatory approval rather than a description of a scientific study characterizing device performance.

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