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

    IPI ALGO-LINE CATHETER

    K Number: K911382 · Decision Jul 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    40
    Review Days
    112

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    Basic Information

    Device Name
    IPI ALGO-LINE CATHETER
    K Number
    K911382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    March 28, 1991
    Decision Date
    July 18, 1991
    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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