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

    CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER

    K Number: K851613 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    4
    Review Days
    61

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    Basic Information

    Device Name
    CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
    K Number
    K851613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Centrimed Corp.
    Date Received
    April 19, 1985
    Decision Date
    June 19, 1985
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by Centrimed Corp.

    K Number Device Name
    K851614 CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
    K851615 CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
    K842007 CENTRIMED SYSTEM 1