Vietnam MOH registration 2400939ĐKLH/BYT-HTTB
The device for displaying the force of contact of the catheter tip on the heart wall
VN: Thiết bị hiển thị lực tiếp xúc của đầu ống thông trên thành tim
Vietnam·Risk Class TTBYT Loại C·TactiSys Quartz Equipment·St. Jude Medical·Registered Jul 21, 2024Registration details
- Analysis ID
- 2400939ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230306-0007
- Product Type
- TactiSys Quartz Equipment
- Product Code
- PN-004 400
Company information
- Manufacturer
- St. Jude Medical
- Manufacturer Country
- UNITED STATES
- Product Owner
- St. Jude Medical
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ KHẢI VINH
Technical details
- Intended Use
- 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
- Registration Date
- Jul 21, 2024
About this record
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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