PTCA Guiding Catheter with Shapeable Balloon - Vietnam Registration 2402799ĐKLH/BYT-HTTB
Access comprehensive regulatory information for PTCA Guiding Catheter with Shapeable Balloon 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 2402799ĐKLH/BYT-HTTB and manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.
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Device Details
Registration Details
2402799ĐKLH/BYT-HTTB
18006178/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The PTCA guidewire with a shapeable balloon is indicated for use with the balloon pre-dilation in patients with atherosclerotic stenosis of the coronary arteries, in the presence of the following coronary artery diseases: • Stable or unstable angina • Acute or chronic myocardial infarction • One or more stenoses in the coronary arteries • Re-stenosis of the coronary arteries after coronary artery bypass surgery (CABG) • Re-stenosis of the coronary arteries after PTCA angioplasty • Total occlusion of the main coronary artery
Dates and Status
Oct 22, 2024