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

    INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM

    K Number: K883439 · Decision Oct 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    15
    Review Days
    59

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    Basic Information

    Device Name
    INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
    K Number
    K883439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Blood Systems, Inc.
    Date Received
    August 15, 1988
    Decision Date
    October 13, 1988
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by Medtronic Blood Systems, Inc.

    K Number Device Name
    K944966 UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
    K944957 TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
    K893207 CLOSED CHEST SUPPORT CIRCUIT
    K893678 DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
    K891687 EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
    K891230 MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
    K885154 INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
    K884390 INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER
    K884244 INTERSEPT* PREBYPASS FILTER
    K883086 INTERSEPT*PREBYPASS FILTER
    Search all 15 clearances from Medtronic Blood Systems, Inc. →