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510(k) Data Aggregation

    K Number
    K253203

    Validate with FDA (Live)

    Device Name
    Retrograde Coronary Sinus Perfusion Cannulae
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-02-19

    (146 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K860149,K953945
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These cannulae are indicated for CPB procedures requiring delivery of cardioplegia in a retrograde direction through the coronary sinus for up to 6 hours in duration.

    Device Description

    The Retrograde Coronary Sinus Perfusion Cannulae models in scope of this 510(k) consist of a wire-wound silicone cannula body with a beveled tip (6-Fr models have a non-wire wound cannula body). Two side holes are present near the tip. The back of the cannula body terminates in a locking female luer. A pressure monitoring line is an integral part of the cannula body, beginning at the tip and terminating in a locking female luer fitting or 3-way stopcock with a locking female luer fitting. An inflatable balloon is located at the distal beveled tip. The inflation assembly is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. Cannulae have a guidewire or solid stylet with a male luer handle or a TruTouch handle.

    AI/ML Overview

    N/A

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