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510(k) Data Aggregation

    K Number
    K120981
    Device Name
    2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
    Manufacturer
    MEDICAL COMPONENTS INC
    Date Cleared
    2012-05-02

    (30 days)

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

    The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system for peripheral infusion of fluids, blood products, medication, and nutritional therapy.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "2.6F Vascu-PICC". This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

    The letter states that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory pathway for certain medical devices. It primarily focuses on the regulatory classification, applicable regulations, and administrative information regarding the device's marketability.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The document is not an AI/ML device submission or a performance study report.

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