Device typeCardiac cryosurgical system: A mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It typically includes a console, monitor, connection cable(s), electrocardiogram (ECG) electrodes, and a cryoablation catheter in which extremely low temperatures are achieved through expansion of a pressurized liquid refrigerant (e.g., nitrous oxide) at the catheter tip; monitoring is achieved via ECG displays and sensors within the catheter.
FDA categoryCardiac ablation percutaneous catheter, Protector, dental, Restraint, patient, conductive
Device ID00763000486778
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information