BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS

    K Number: K992476 · Decision Sep 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    415

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    Basic Information

    Device Name
    PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
    K Number
    K992476
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pilling Weck Surgical
    Date Received
    July 26, 1999
    Decision Date
    September 13, 2000
    Product Code
    MWS
    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
    MWS Stabilizer, Heart

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