Device typeRenal denervation ultrasound system catheter: An electrically-powered, steerable, thin, flexible tube intended to be introduced percutaneously into the renal artery to emit ultrasound energy, with simultaneous arterial wall cooling to prevent arterial wall damage, for renal denervation (RDN). It includes a distal ultrasound transducer and balloon for the circulation of cooling fluids. This is a single-use device.
FDA categoryAblation Catheter, Renal Denervation
Device ID00810008950067
Catalog numberPRDS-063-02
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Unsafe
Balloon Diameter3.5 Millimeter