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510(k) Data Aggregation

    K Number
    K151981
    Device Name
    Turnpike catheter
    Manufacturer
    VASCULAR SOLUTION, INC.
    Date Cleared
    2015-08-13

    (27 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K142065
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR SOLUTION, INC.

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

    The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

    Device Description

    The Turnpike catheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations and one of two working lengths. The Turnpike catheters are hydrophilic coated and are compatible with 0.014" guidewires and 5F guide catheters.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Turnpike Catheter and does not contain information about the acceptance criteria or a study proving that a device meets such criteria. This document is related to a labeling change for the device and states that no tests were necessary to demonstrate substantial equivalence because there was no indication or technology change.

    Therefore, I cannot provide the requested information based on the provided text.

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