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

    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

    K Number: K022107 · Decision Aug 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    41

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    Basic Information

    Device Name
    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
    K Number
    K022107
    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
    June 28, 2002
    Decision Date
    August 8, 2002
    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.

    K Number Device Name
    K050172 CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
    K023427 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
    K010261 CARDIOMEDICS ECP SYSTEM
    K872034 CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM