The device for displaying the force of contact of the catheter tip on the heart wall - Vietnam Registration 2400939ĐKLH/BYT-HTTB
Access comprehensive regulatory information for The device for displaying the force of contact of the catheter tip on the heart wall in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400939ĐKLH/BYT-HTTB and manufactured by St. Jude Medical. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ KHẢI VINH.
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Device Details
Registration Details
2400939ĐKLH/BYT-HTTB
000.00.04.G18-230306-0007
TactiSys Quartz Equipment
PN-004 400
Technical Details
The designated equipment to be used in conjunction with the cardiac ablation catheter, the EnSite Cardiac Mapping System with the EnSite Contact Force Module and the Radiofrequency (RF) Cardiac Ablation Generator Kit. The equipment acquires data from the ablation catheter to calculate the contact force between the catheter tip and the heart wall, transmits this data to the EnSite Contact Force Module, transmits cardiac signals for monitoring, transmits pacing signals, and delivers RF energy to the heart tissue during the ablation treatment of atrial fibrillation by radiofrequency (RF).
Dates and Status
Jul 21, 2024