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

    MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

    K Number: K012898 · Decision Sep 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    43
    Review Days
    19

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    Basic Information

    Device Name
    MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
    K Number
    K012898
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Cardiovascular, Inc.
    Date Received
    August 29, 2001
    Decision Date
    September 17, 2001
    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 Cobe Cardiovascular, Inc.

    K Number Device Name
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    K033641 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
    K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
    K021830 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
    K011835 COBE REVOLUTION
    K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
    K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
    K001509 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
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