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510(k) Data Aggregation

    K Number
    K121007
    Device Name
    NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
    Manufacturer
    DELTA MED SRL
    Date Cleared
    2012-12-28

    (269 days)

    Product Code
    FOZ, FDA
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELTA MED SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neo Delta Self Safe Catheters are intravascular catheters intended for short term use for the intravenous administration of fluids.
    Device Description
    The Delta Med Neo Delta Self Safe 'T' and Self Safe '1' IV Catheters are two ranges of color-coded, single-entry, polyurethane (PUR) IV catheters available in 'non-winged' (the 'T' version) and 'winged' (the '1' version) varieties, in sizes from 14 to 24 gauge. All versions include a passive safety mechanism to protect users from needlestick injuries together with three radiopaque lines to allow x-ray visualization.
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