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

    MCAS (MODULAR CLIP APPLIER SYSTEM)

    K Number: K983744 · Decision Jan 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    7
    Applicant Total
    58
    Review Days
    90

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    Basic Information

    Device Name
    MCAS (MODULAR CLIP APPLIER SYSTEM)
    K Number
    K983744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Resources
    Date Received
    October 23, 1998
    Decision Date
    January 21, 1999
    Product Code
    DSS
    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
    DSS Clip, Vascular

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