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510(k) Data Aggregation

    K Number
    K133626
    Device Name
    AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
    Manufacturer
    MICROVENTION, INC.
    Date Cleared
    2013-12-20

    (24 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K122543
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AZUR PURE is 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

    The AZUR PURE Peripheral Coil System, Pushable 18, consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.

    The subject of this Special 510(k) is the addition of a platinum overcoil to the AZUR PURE Pushable 18 device. The purpose is to improve tracking performance of the coil implant during delivery.

    With the exception of the modification to add the platinum overcoil, the modified devices are identical to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the AZUR PURE Peripheral Coil System, Pushable 18:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test / Test DescriptionAcceptance CriteriaReported Device Performance
    Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance)All performance ratings shall be ≥ 3PASS, acceptance criteria met
    Advancement Force (Measure the force required to advance the coil into the microcatheter)
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