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

    CATHETER,PERCUTANEOUS INTRODUC. & SHEATH

    K Number: K770561 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    12
    Review Days
    34

    Basic Information

    Device Name
    CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
    K Number
    K770561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    USCI, DIV. C.R. BARD, INC.
    Date Received
    March 23, 1977
    Decision Date
    April 26, 1977
    Product Code
    DYB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DYB Introducer, Catheter

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