Device Dossier
Cardioblate LP Surgical Ablation Device - Cardiac radio-frequency ablation system
Device Dossier for Cardioblate LP Surgical Ablation Device - Cardiac radio-frequency ablation system (Cardiac radio-frequency ablation system, Class III,…
- GMDN category: Cardiac radio-frequency ablation system
Intended purpose
The device is intended to create transmural lesions in atrial cardiac tissue using irrigated radiofrequency energy under direct or endoscopic visualization in surgical procedures, including minimally invasive surgical procedures.
Functional description
The Cardioblate LP surgical ablation device is a hand-held, single-use, bipolar, radiofrequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. The device is intended for intermittent operation.