b0f42e10-c15d-4ebf-b718-f26bbe329247UpdatePublished42023-12-082022-07-112023-11-01Not in Commercial Distribution00685447012467PrimaryGS1VersaCross Large Access SolutionVLAK0007NA249225954Baylis Médicale Cie Inc11 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse5144889801info@baylismedical.com47247Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.falseActiveDXFCatheter, SeptostomyDREDilator, Vessel, For Percutaneous CatheterizationDevice Size Text, specify12.5F 85cm VersaCross Large Access Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-Tip VersaCross RF Wire OD=0.035in/10ft/3m Connector Cabletruefalse