BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TE ME NA EPIDURAL CATHETER

    K Number: K991259 · Decision Feb 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    680

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TE ME NA EPIDURAL CATHETER
    K Number
    K991259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Te ME NA S.A.R.L.
    Date Received
    April 13, 1999
    Decision Date
    February 21, 2001
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BSO), ordered by most recent decision date.

    EDEN ControlCath

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Perifix FX Catheter; Contiplex FX Catheter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SubQKath Catheter and Needle Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Percutaneous Introducer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C-CAT Anaesthesia Catheter kit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Te ME NA S.A.R.L.

    K Number Device Name
    K990323 TE ME NA POLYSTIM NERVE STIMILATOR
    K002405 SPINAL EPIDURAL NEEDLES
    K990100 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    K990020 TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC