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

    CARDIOMEDICS ECP SYSTEM

    K Number: K010261 · Decision Feb 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    CARDIOMEDICS ECP SYSTEM
    K Number
    K010261
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardiomedics, Inc.
    Date Received
    January 29, 2001
    Decision Date
    February 28, 2001
    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
    K022107 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
    K872034 CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM