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510(k) Data Aggregation

    K Number
    K191488
    Device Name
    SAM IO Intraosseous Access System
    Manufacturer
    SAM® Medical Products, Inc.
    Date Cleared
    2019-11-21

    (170 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAM® Medical Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAM IO™ Intraosseous Access System provides Intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatic patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
    Device Description
    The SAM IO™ Intraosseous Access System consists of a single use disposable intraosseous (IO) needle assembly (the SAM IO™ Needle Set) that connects to a reusable manually powered drill (the SAM™ IO Driver). Upon manual activation, the Driver penetrates through the cortex of the bone to a desired depth within the bone marrow by means of rotary cutting action along with force applied axially by the operator. The Driver can then be separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The stylet containing the driver connection is then removed. The needle insertion can also be performed by hand without the use of the Driver as per the user's discretion. A standard Luer lock (part of the needle assembly) permits attachment of standard syringes and IV lines for administration of drugs and fluids.
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