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

    HEPARIN ASSAY CARTRIDGES AND CONTROLS

    K Number: K944115 · Decision Mar 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    213

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    Basic Information

    Device Name
    HEPARIN ASSAY CARTRIDGES AND CONTROLS
    K Number
    K944115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Hemotec, Inc.
    Date Received
    August 23, 1994
    Decision Date
    March 24, 1995
    Product Code
    GFT
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GFT Protamine Sulphate

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    Other Clearances by Medtronic Hemotec, Inc.

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    K954202 PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
    K940426 MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
    K923594 CLOTTRAC COAGULATION CONTROL
    K922031 HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL