ef8f4345-0c41-43a5-b4db-f30878854c55UpdatePublished42023-12-042016-09-19In Commercial DistributionM781DF10135901PrimaryHIBCCTwinFlo™ CatheterDF10-135/90138648154Thermopeutix, Inc.1The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lumens, IFL and OFL) that can infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are two additional smaller lumens; one lumen is used for inflation of the distal balloon on the inflow lumen while the second small lumen permits pressure monitoring distal to the balloon. Inflation of the balloon isolates the region distal to the balloon permitting infusion into the vascular region of interest. When used to provide perfusion or control blood flow, blood exits via the outflow lumen to an extracorporeal circuit and is returned via the inflow lumen distal to the inflated balloon. The catheter is supplied with hydrophilic coating.falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-858-549-1760customer.service@thermopeutix.com32584Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.falseActiveMJNCatheter, Intravascular Occluding, TemporaryDevice Size Text, specifySheath Compatibility: 14 FrDevice Size Text, specifyOutflow Length: 90 cm Device Size Text, specifyInflow Length: 135 cmDevice Size Text, specifyBalloon Diameter: 10.0 mmHandling Environment Temperaturetruefalse