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

    CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000

    K Number: K050172 · Decision Mar 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    64

    Basic Information

    Device Name
    CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
    K Number
    K050172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CARDIOMEDICS, INC.
    Date Received
    January 26, 2005
    Decision Date
    March 31, 2005
    Product Code
    DRN
    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
    DRN Device, Counter-Pulsating, External

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    Other Clearances by CARDIOMEDICS, INC.

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    K022107 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
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