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

    THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)

    K Number: K883412 · Decision Feb 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    177

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    Basic Information

    Device Name
    THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
    K Number
    K883412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Promedica Products, Inc.
    Date Received
    August 15, 1988
    Decision Date
    February 8, 1989
    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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