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510(k) Data Aggregation

    K Number
    K991259
    Device Name
    TE ME NA EPIDURAL CATHETER
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2001-02-21

    (680 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K060186
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetic and/or analgesic solutions into the epidural or Caudal space for up to 72 hours.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry. This document is a 510(k) clearance letter from the FDA to Te Me Na S.A.R.L. for their Model C20900-03 Polymedic Epidural Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    The document does not contain information about any AI/ML device, clinical study, acceptance criteria for an AI/ML device, or device performance metrics. Therefore, I cannot provide the requested information based on this text.

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