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510(k) Data Aggregation

    K Number
    K253998

    Validate with FDA (Live)

    Device Name
    Clearview Intracoronary Shunts
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-20

    (39 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    18 - 999
    Reference & Predicate Devices
    K120612
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.

    Device Description

    The disposable intracoronary shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material with 14 mm between the ends. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. These devices are sterile, nonpyrogenic, disposable and intended for single use only. They are sterilized using ethylene oxide and are categorized as external communicating devices, with limited contact (<=24 hours) circulating blood contact.

    AI/ML Overview

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