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

    NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

    K Number: K934847 · Decision Apr 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    15
    Review Days
    189

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    Basic Information

    Device Name
    NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
    K Number
    K934847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sorin Biomedical, Inc.
    Date Received
    October 8, 1993
    Decision Date
    April 15, 1994
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Sorin Biomedical, Inc.

    K Number Device Name
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    K963758 CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
    K963759 DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
    K964908 VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
    K964907 VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
    K961869 DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
    K952270 DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
    K945198 DIDECO PEDIATRIC ARTERIAL FILTERS
    K945065 DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
    K941215 VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
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