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510(k) Data Aggregation

    K Number
    K111307
    Device Name
    AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
    Manufacturer
    MICROVENTION, INC.
    Date Cleared
    2011-06-15

    (36 days)

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

    Intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA regarding the clearance of the AZUR Detachable 35 Platinum Coil System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot provide the requested information based on this document.

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