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510(k) Data Aggregation

    K Number
    K970669
    Device Name
    AEROQUIP SAFESTART IV CATHETER
    Date Cleared
    1997-08-01

    (158 days)

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

    AEROQUIP MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drug and fluids into patients via a standard luer connection. The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.
    Device Description
    The Aeroquip SafeStart™ IV Catheter device is a sterile, non-pyrogenic, disposable, peripheral vascular access catheter. The catheter check valve assembly consists of a catheter tube, a twoway internal check valve, a catheter body and a luer lock interface cap.
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    K Number
    K970644
    Device Name
    AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
    Date Cleared
    1997-07-31

    (161 days)

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

    AEROQUIP MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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