Device Dossier

Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use

Device Dossier for Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use (Endoscopic electrosurgical electrode,…

Intended purpose

The Nykanen Radiofrequency Wire is intended to create an atrial septal defect in the heart. The intended use of the Connector Cable is to connect the RFP-100A Generator to separately cleared compatible RF devices.

Functional description

The Kit consists of the Nykanen Radiofrequency Wire and Baylis Single-Use Connector Cable. The Cable enables RF power delivery from the RF Generator to the Wire. The Wire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and an external electrode. The Wire is usually inserted into the femoral vein and positioned into the appropriate chamber of the heart under fluoroscopy. Once positioned RF power is delivered resulting in puncture of targeted cardiac tissue.

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