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510(k) Data Aggregation
K Number
K192038Device Name
Emprint Visualization Application
Manufacturer
Covidien LLC.
Date Cleared
2019-12-02
(125 days)
Product Code
LLZ
Regulation Number
892.2050Why 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
K190753Device 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
870.1250Why 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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