BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    SAFE-1

    K Number: K893704 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    8
    Review Days
    218

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    Basic Information

    Device Name
    SAFE-1
    K Number
    K893704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Polystan C/O Vitalcor, Inc.
    Date Received
    May 18, 1989
    Decision Date
    December 22, 1989
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Polystan C/O Vitalcor, Inc.

    K Number Device Name
    K894657 POLYSTAN HEART-LUNG MACHINE SYSTEM
    K893940 POLYSTAN HEATER-COOLER UNIT
    K893705 SAFE-1 VENOUS RESERVOIR
    K874853 POLYSTAN TWO STAGE CATHETERS
    K874852 POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
    K872182 POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
    K843538 PO 2 LYTRODE