LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993463
    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    CUSTOM ASSEMBLIES, INC.
    Date Cleared
    2000-01-04

    (83 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K940319,K991932
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
    Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.

    Device Description

    The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission for a medical device (Extension set/Intravascular Administration Set), focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1