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

    CARDIOTOMY RESERVOIR W/20 MICRON FILITER

    K Number: K920178 · Decision May 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    23
    Review Days
    485

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    Basic Information

    Device Name
    CARDIOTOMY RESERVOIR W/20 MICRON FILITER
    K Number
    K920178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    January 14, 1992
    Decision Date
    May 13, 1993
    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 Lifestream Int'L, Inc.

    K Number Device Name
    K964571 VISION CARDIOPLEGIA DELIVERY SYSTEM
    K962354 DIOMED 15, 30, 60 SURGICAL DIODE LASER
    K920618 AUTOTRANSFUSION SUCTION SET
    K913181 AUTOLOGOUS BLOOD PROCESSING SYSTEM
    K914396 SURGI LIGHT NON-CONTACT FIBERS
    K912045 TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
    K911523 MODIFICATION TO MODEL 90-1460 LASER ADAPTER
    K910726 LIGHT-TOUCH AND SURGI LIGHT FIBERS
    K904491 TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
    K903709 SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
    Search all 23 clearances from Lifestream Int'L, Inc. →