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510(k) Data Aggregation

    K Number
    K252295

    Validate with FDA (Live)

    Device Name
    Ryurei
    Manufacturer
    Terumo Corporation
    Date Cleared
    2026-03-27

    (247 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K220629,K141025,K141236,K163372,K180921
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K220629, K141025, K141236, K163372

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

    Ryurei (1.5 mm) is indicated for:

    • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
    • Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

    Ryurei (2.0–4.0 mm) is indicated for:

    • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
    • Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
    • Balloon post-deployment expansion of balloon expandable stents (bare metal and drug-eluting).
    Device Description

    The tip of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures.
    One or two radiopaque markers inside the balloon.
    On the shaft, there are two depth markers.
    Double-lumen structure, with a guidewire lumen and an inflation lumen.
    A hub is attached to the balloon for inflation/deflation.
    The surface of catheter is coated with hydrophilic polymer coating.

    AI/ML Overview

    N/A

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