Device typeCardiac radio-frequency ablation system catheter: A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.
FDA categorycatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Device ID10846835003192
Catalog numberBNI35DDH
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information