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

    VISION CARDIOPLEGIA DELIVERY SYSTEM

    K Number: K964571 · Decision Aug 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    23
    Review Days
    267

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    Basic Information

    Device Name
    VISION CARDIOPLEGIA DELIVERY SYSTEM
    K Number
    K964571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    November 14, 1996
    Decision Date
    August 8, 1997
    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 Lifestream Int'L, Inc.

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    K904491 TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
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