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510(k) Data Aggregation

    K Number
    K260499

    Validate with FDA (Live)

    Device Name
    Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
    Manufacturer
    Abbott Medical
    Date Cleared
    2026-03-13

    (28 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K190581
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

    Device Description

    The Amplatzer Trevisio Intravascular Delivery System is designed to deliver Amplatzer Occluders including Amplatzer Septal Occluder (ASO), Amplatzer Multifenestrated Septal Occluder - "Cribriform," Amplatzer™ PFO Occluder, Amplatzer Muscular VSD Occluder and the Amplatzer P.I. Muscular VSD Occluder. The occluder and delivery system are shipped separately.

    AI/ML Overview

    N/A

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