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510(k) Data Aggregation

    K Number
    K041844
    Device Name
    ALL SAFE HUBER SAFETY INFUSION SETS
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2004-09-03

    (57 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALL SAFE HUBER SAFETY INFUSION SETS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AllSafeTM Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The AllSafeTM Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.

    Device Description

    All Safe Huber Safety Infusion Sets

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA regarding a medical device called "All Safe Huber Safety Infusion Sets". It is not a study report and therefore does not contain the information requested about acceptance criteria, device performance, study design, or ground truth establishment.

    A 510(k) letter primarily indicates that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not provide details of performance studies in the way a clinical trial report or a scientific publication would.

    To answer the prompt, one would need access to the actual studies conducted by Nexus Medical, LLC to support their 510(k) submission, which are not provided in this document.

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