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

    SIGNATURE(TM) CUSTOM TUBING PACK

    K Number: K924529 · Decision Jun 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    288

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    Basic Information

    Device Name
    SIGNATURE(TM) CUSTOM TUBING PACK
    K Number
    K924529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Avecor Cardiovascular, Inc.
    Date Received
    September 8, 1992
    Decision Date
    June 23, 1993
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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