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510(k) Data Aggregation

    K Number
    K192038
    Device Name
    Emprint Visualization Application
    Manufacturer
    Covidien LLC.
    Date Cleared
    2019-12-02

    (125 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Covidien LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.
    Device Description
    The Emprint™ Visualization Application is a software product that achieves its medical purpose without being part of the hardware of a medical device (SaMD). The Emprint™ Visualization Application is used to support Emprint ™-system ablation procedures by displaying patient CT and MRI images with modeled ablation zones / volumes. The application is a Windows™ desktop program that is installed on a hospital computer with local storage and a network connection. The software receives CT and MRI images by supporting DICOM connections with CT/MRI scanners and hospital PACS. The software's DICOM image viewer does not in any way alter the medical images. The device is designed to meet the procedure planning and evaluation needs of physicians conducting soft tissue ablation procedures using Emprint ™-branded systems only.
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    K Number
    K190753
    Device Name
    EverCrossTM 0.035 OTW PTA Dilatation Catheter
    Manufacturer
    Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.)
    Date Cleared
    2019-04-23

    (29 days)

    Product Code
    LIT, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ev3 Inc, Covidien llc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
    Device Description
    EverCross 0.035" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant balloon and an atraumatic tapered tip. The distal portion of the catheter, proximal to the balloon, has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. The EverCross 0.035" OTW PTA Dilatation Catheter is available in multiple balloon sizes and three catheter working lengths. Nominal balloon diameter and length are printed on the strain relief.
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