Vietnam MOH registration 2300055ĐKLH/BYT-TB-CT

Cardiac Physiologic Radiofrequency Catheter

VN: Catheter đốt điện sinh lý tim

Vietnam·Risk Class TTBYT Loại D·Safire Bi-Directional Ablation Catheter·St. Jude Medical·Registered Feb 15, 2023

Registration details

Analysis ID: 2300055ĐKLH/BYT-TB-CT
Submission ID: 000.00.04.G18-220308-0004
Product Type: Safire Bi-Directional Ablation Catheter
Product Code: 402818, 402819, 402820, 402821, 402822, 402823, 402825, 402826, 402828, 402829

Company information

Manufacturer: St. Jude Medical
Manufacturer Country: UNITED STATES

Technical details

Intended Use: Designed for use in the recording, mapping and/or temporary pacing of the heart and for the radiofrequency (RF) ablation of cardiac tissue in conditions involving the formation or maintenance of rapid ventricular arrhythmias. The Safire catheter is designed to be used with an RF generator that meets the following specifications: -Frequency: 450-575 Kilohertz -Voltage: 0-140 Volts -Current: 0-2.0 Amps

Dates and status

Registration Date: Feb 15, 2023

About this record

Access comprehensive regulatory information for Cardiac Physiologic Radiofrequency Catheter in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2300055ĐKLH/BYT-TB-CT and manufactured by St. Jude Medical.

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