Device typeRenal denervation radio-frequency ablation catheter: A sterile, steerable, thin, flexible tube containing one or more monopolar electrodes intended to be introduced percutaneously into the renal artery to transmit precisely-focused radio-frequency (RF) current, from a connected RF generator, to disrupt renal nerves for therapeutic denervation of the kidney; commonly known as renal denervation (RDN). The device has embedded metallic electrodes and may be available in a variety of forms (e.g., deflectable tip, balloon catheter). This is a single-use device.
FDA categoryAblation catheter, renal denervation
Device ID00763000354466
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size1.78 MM Minimum Inner Diameter
Size1.32 MM Outer Diameter
Size117 CM Effective Length
Size19 MM Tip Diameter
Size6 FR Guide Catheter
Size0.36 MM Maximum Guidewire Diameter