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510(k) Data Aggregation

    K Number
    K072602
    Device Name
    VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
    Manufacturer
    MEDPRO SAFETY PRODUCTS, INC.
    Date Cleared
    2008-06-18

    (278 days)

    Product Code
    FMI,MEG
    Regulation Number
    880.5570
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K003406,K003461
    Predicate For
    K111424
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

    Device Description

    The VACUETTE® PREMIUM Safety Needle System is a single use, sterile holder designed with an integrated, multiple sample needle and safety shield to provide protection against needlestick injury during venipuncture.

    AI/ML Overview

    The provided text is a 510(k) summary for the VACUETTE® PREMIUM Safety Needle System. This document focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies.

    Therefore, I cannot provide the requested information from the given text. The document acts as a regulatory submission for market clearance, not a clinical or performance study report.

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