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510(k) Data Aggregation

    K Number
    K984561
    Device Name
    SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
    Manufacturer
    MSR, INC.
    Date Cleared
    1999-02-04

    (43 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MSR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model A & B Subcutaneous Infusion Set is intended to be used to administer insulin and medications under the skin.
    Device Description
    The MSR Model A and Model B Subcutaneous Infusion Sets connect at the female luer connection to a reservoir containing insulin or other medications delivered by an infusion pump. The 28 gauge AISI 304 stainless steel introducer needle and 25 gauge soft cannula connected to the hub is inserted into the subcutaneous tissue . The introducer needle is removed and the hub and soft cannula remains in place. The Model B Subcutaneous Infusion Set has a 28 gauge AIS1 needle connected to a hub is inserted directly into the subcutaneous tissue. The cannula hub are affixed by an acrylic medical grade adhesive. The tubing is polvethylene lined polyurethane has a female Luer on one end and a connector that attaches to the hub on the other end. The tubing set portion can be removed and capped off when the pump is not in use while the hub and cannula remain in place.
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