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

    CARBOMEDICS MITRAL ROTATOR

    K Number: K960923 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    22
    Review Days
    54

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    Basic Information

    Device Name
    CARBOMEDICS MITRAL ROTATOR
    K Number
    K960923
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3935
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbomedics, Inc.
    Date Received
    March 6, 1996
    Decision Date
    April 29, 1996
    Product Code
    MOP
    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
    MOP Rotator, Prosthetic Heart Valve

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    K955588 VASCUTEK GRAFT SIZER SET
    K952184 CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
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    Search all 22 clearances from Carbomedics, Inc. →