Aneurysm of the Aorta - Vietnam Registration 2301315ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Aneurysm of the Aorta 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 2301315ĐKLH/BYT-HTTB and manufactured by Balton Sp.zo.o..
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Device Details
Registration Details
2301315ĐKLH/BYT-HTTB
000.00.04.G18-211105-0016
Valver Valvuloplasty Catheters
VALB231823X40110; VALB252025X40110; VALB282328X40110; VALB312631X40110.
Technical Details
Translating the text to English: Endovascular Aortic Balloon Dilatation is a procedure performed in the treatment of various types of aortic valve stenosis. This procedure has rather limited indications, including: The situation where the patient is prepared for a valve repair surgery, but the patient's condition requires immediate intervention; Severe aortic stenosis with significant symptoms; The event where the patient has severe aortic valve stenosis requiring urgent surgery unrelated to the heart; Severe aortic valve stenosis in patients who, despite the severity of the condition, do not meet the criteria for heart valve replacement surgery; In children and adolescents - to allow for a delay in valve repair surgery for a period of a few to several years
Dates and Status
Oct 11, 2023