5 results
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27ms
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Sources: EU EUDAMED, US FDA
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
FDA Enforcement
Class II
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·September 4, 2013
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Enforcement
Class II
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·October 3, 2012
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Enforcement
Class II
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·October 3, 2012
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
FDA Enforcement
Class II
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·October 21, 2015
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
FDA Enforcement
Class II
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·September 19, 2018