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510(k) Data Aggregation

    K Number
    K091750
    Device Name
    GUIDELINER CATHETER, MODELS 5571, 5572, 5573
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2009-11-04

    (141 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K082337
    Predicate For
    K112082,K112100
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.

    Device Description

    The GuideLiner is a catheter that consists of a single lumen distal tube (with a radiopaque marker band at the distal tip) secured to a proximal shaft. GuideLiner catheters are available in three sizes for use with 6F, 7F or 8F guide catheters. The catheters are packaged in a dispenser coil inside a single sterile barrier pouch and sterilized by ethylene oxide.

    AI/ML Overview

    The provided text is a 510(k) summary for the GuideLiner catheter, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device, device description, and intended use.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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