2682cc07-580a-4124-873d-9151dc6c78f2UpdatePublished32024-08-072016-04-27In Commercial DistributionB094CC01000PrimaryHIBCCCenterCross CatheterCC-0100055819211ROXWOOD MEDICAL, INC.1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse46719Atheroma crossing microdissection catheter, coronaryA manually-powered (non-electronic) instrument intended to be used to create a pathway through an occluded coronary artery to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [chronic total occlusion (CTO)], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.falseActiveDQYCatheter, Percutaneoustruefalse