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510(k) Data Aggregation

    K Number
    K964042
    Device Name
    EXTRESAFE PHLEBOTOMY
    Manufacturer
    SPECIALIZED HEALTH PRODUCTS, INC.
    Date Cleared
    1997-06-06

    (241 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXTRESAFE PHLEBOTOMY

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

    The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure f 11 following use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the Extresafe™ Phlebotomy device. This document does not describe any acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

    Therefore, I cannot provide the requested information from the given document as it is not present.

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