593650e1-1cd4-42e1-9053-2f9c5f70d3fbNewPublished12025-11-132025-11-05In Commercial Distribution00810024671748PrimaryGS1AuST Steerable Sheath0-100H-H3574SAN5-SNSP0117126091CENTERPOINT SYSTEMS LLC1The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK25105100017846Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.falseActiveDYBIntroducer, CatheterDRACatheter, SteerableDevice Size Text, specifyCatheter Inner Diameter, French Size = 10FDevice Size Text, specifyOuter Diameter, French Size = 14.1FCatheter Working LengthDevice Size Text, specifyDistal Deflection Diameter, Primary = 35mmDevice Size Text, specifyDistal Deflection Diameter, Secondary = 50mmtruefalse