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510(k) Data Aggregation

    K Number
    K254278

    Validate with FDA (Live)

    Device Name
    Arterial Pressure Monitoring Set/Tray
    Manufacturer
    Spectrum Vascular
    Date Cleared
    2026-03-25

    (85 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K180846,K180792
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.

    • 2.5 French catheters are intended for patients from birth and older.
    • 3.0 and 4.0 French catheters are intended for patients aged 1 year and older.
    • 5.0 French catheters are intended for patients aged 12 years and older.
    Device Description

    The Arterial Pressure Monitoring Set/Tray is intended to be used for arterial pressure monitoring and blood sampling. The pressure monitoring catheter is inserted into the vasculature using the Seldinger technique. Based on the device length, the subject device may gain access via the radial artery, femoral artery, or distal aorta.

    The Arterial Pressure Monitoring Set/Tray is comprised of a pressure monitoring catheter, wire guide, entry access needle, and syringe. The Arterial Pressure Monitoring Set/Tray is supplied sterile and intended for one-time use.

    AI/ML Overview

    N/A

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