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510(k) Data Aggregation

    K Number
    K253511

    Validate with FDA (Live)

    Device Name
    Concerto Versa™ Detachable Coil
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-14

    (70 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K202850
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

    Device Description

    The Concerto Versa™ Detachable Coil is an embolization coil indicated for arterial and venous embolization in the peripheral vasculature. It consists of a platinum-tungsten embolization implant coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately. The Concerto Versa™ Detachable Coil is for single use and provided sterile.

    AI/ML Overview

    N/A

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