39b38877-fef4-4277-9739-b169fe6bef64UpdatePublished52023-12-042016-09-15In Commercial DistributionM78110445451PrimaryHIBCCTAPAS® Catheter 104-4545138648154Thermopeutix, Inc.1The TAPAS® Catheter consists of a two concentric tubular shafts (proximal occlusion balloon and distal occlusion balloon, POB and DOB, respectively) and is used to infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The proximal infusion lumen (Red) may be accessed using external devices connected to this lumen. There are three additional smaller lumens: one lumen is used for inflation of the balloon on the DOB; one lumen is used for inflation of the balloon on the POB; and one lumen permits pressure monitoring (Yellow) distal to the proximal occlusion balloon. The simultaneous inflation of the balloons may isolate a target region within a vessel and allow the infusion of a fluid agent into the vascular region of interest. The catheter is supplied with hydrophilic coating.falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-858-549-1760customer.service@thermopeutix.comK11221900032584Intravascular 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: 7 FrDevice Size Text, specifyTreatment Length: 15 mm - 300 mmDevice Size Text, specifyDistal Balloon Useable Shaft Length: 165 cmDevice Size Text, specifyProximal Balloon Shaft Length: 135 cmDevice Size Text, specifyDistal Balloon Diameter: 4.5 mmDevice Size Text, specifyProximal Balloon Diameter: 4.5 mmHandling Environment Temperaturetruefalse