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510(k) Data Aggregation

    K Number
    K071330
    Device Name
    GALTSTICK INTRODUCER SYSTEM
    Manufacturer
    GALT MEDICAL CORP.
    Date Cleared
    2007-10-31

    (173 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K000737
    Why did this record match?
    Device Name :

    GALTSTICK INTRODUCER SYSTEM

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

    The Galtstick™ Introduce system is indicated for percutaneous introduction and place of catheters and guidewires.

    Device Description

    The Galtstick™ device adds a stiffening cannula with an attached hub for ease of insertion into the body.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a medical device called the "Galtstick™ Introducer System." This document is a letter from the FDA to Galt Medical Corporation, notifying them that their device has been found substantially equivalent to a legally marketed predicate device.

    This document does not describe acceptance criteria for device performance or a study proving that the device meets such criteria.

    The content relates to regulatory clearance based on substantial equivalence to a predicate device, rather than a performance study with defined acceptance criteria and results. The information provided is primarily administrative and regulatory. Therefore, I cannot extract the requested information about acceptance criteria and a study from this document.

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