b3cc4d21-0edf-450b-bec9-61b2ef4dde70UpdatePublished32018-07-062015-09-10In Commercial DistributionM097ABR03460PrimaryHIBCCB-Rail 3.5F Delivery CatheterABR-0346ABR-0346789032039BEST VASCULAR, INC.1B-Rail 3.5F Delivery Catheter for the Novoste Beta-Cath SystemfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse770-717-0904xx@xx.xxP000018000P000018015P00001804061707Coronary artery brachytherapy system applicator, manual-afterloadingA sterile flexible tube intended to deliver/remove radiation therapy sources into a coronary artery, typically into the lumen of an implanted stent, as part of a manual-afterloading brachytherapy system. It is introduced into the patient and subsequently connected to the brachytherapy system source transfer device; it includes radiopaque markers to monitor the position of the radiation source. Disposable devices associated with the procedure may be included (e.g., syringe, connectors). This is a single-use device.falseActiveMOUIntravascular Radiation Delivery Systemtruefalse