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510(k) Data Aggregation

    K Number
    K041468
    Device Name
    PREMICATH, 1261.205
    Manufacturer
    VYGON CORP.
    Date Cleared
    2004-09-09

    (99 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization. The catheter is used for mid- to long-term infusion of TPN or intravenous medications.

    Device Description

    Premicath is a peripherally inserted central (PIC) catheter for central venous catheterization.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Premicath". It discusses regulatory approval and substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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