3 results
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6ms
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Sources: EU EUDAMED, US FDA
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
FDA Enforcement
Class I
·Terminated·Edwards Lifesciences, LLC·June 19, 2019
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.
FDA Enforcement
Class I
·Terminated·Cook, Inc.·May 22, 2013
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD . improve blood flow to the extremity.
FDA Enforcement
Class I
·Terminated·Cook, Inc.·May 22, 2013