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

    MALLEABLE SHAFT CLAMP

    K Number: K011078 · Decision Jul 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    63
    Review Days
    95

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    Basic Information

    Device Name
    MALLEABLE SHAFT CLAMP
    K Number
    K011078
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    April 9, 2001
    Decision Date
    July 13, 2001
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Allegiance Healthcare Corp.

    K Number Device Name
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    K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K023425 DRAPES WITH ABSORBENT REINFORCEMENT
    K022765 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023170 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023167 BREATHABLE SURGICAL GOWN
    K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
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