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510(k) Data Aggregation

    K Number
    K182538
    Device Name
    Merit RadialFlo Arterial Catheter
    Date Cleared
    2019-01-16

    (124 days)

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

    Merit Medical Singapore Pte. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
    Device Description
    The Merit RadialFlo Arterial Catheter is an intravascular catheter designed to access the vasculature to sample blood and monitor blood pressure. The device is equipped with a Floswitch to limit blood spill or control flow as needed. The needle includes a unique notch to provide instant blood return upon vessel entry. The radiopaque catheter provides visibility under X-ray and fluoroscopy. The arterial catheter is intended to be in contact with the circulating blood for a prolonged (24 hours to 30 days) duration. The steel needle is in contact with circulating blood for a limited (<24 hours) duration and the flow control plug has indirect blood path contact. All the materials used in Merit RadialFlo Arterial Catheter are biocompatible.
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