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510(k) Data Aggregation

    K Number
    K253769

    Validate with FDA (Live)

    Device Name
    Instylla Delivery Kit
    Manufacturer
    Instylla, Inc.
    Date Cleared
    2025-12-22

    (27 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Special
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K213632
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline, and other aqueous solutions.

    Device Description

    The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link). The barrel contains a fixed male luer connector, which is compatible with female luer hubs.

    The Instylla Delivery Kit is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) 1mL commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.

    The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).

    AI/ML Overview

    N/A

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