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510(k) Data Aggregation

    K Number
    K252402

    Validate with FDA (Live)

    Device Name
    Midline Catheter
    Manufacturer
    Terumo Medical Products (Hangzhou) Co., Ltd.
    Date Cleared
    2025-12-18

    (140 days)

    Product Code
    PND
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K162377
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Midline Catheter is indicated for insertion into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Midline Catheter is suitable for use with power injectors.

    Device Description

    The Midline Catheter is a peripherally inserted catheter composed of a radiopaque polyurethane catheter, a catheter slider, a catheter hub, needle hub, and 3D-Shin™ needle featuring an engineered three-dimensional geometry of the needle tip, with a passive safety mechanism. After observing the blood return, the 3D-Shin™ needle is withdrawn, and the needle tip is fully covered by the safety mechanism, reducing the risk of accidental needlestick injury.

    AI/ML Overview

    N/A

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