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

    MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM

    K Number: K965251 · Decision Mar 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    475
    Review Days
    89

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    Basic Information

    Device Name
    MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
    K Number
    K965251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Vascular
    Date Received
    December 19, 1996
    Decision Date
    March 18, 1997
    Product Code
    MAJ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MAJ Catheter, Percutaneous, Intraspinal, Short Term

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