Peripheral blood vessel hypoxic shadow covered with paclitaxel - Vietnam Registration 2400478ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Peripheral blood vessel hypoxic shadow covered with paclitaxel 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 2400478ĐKLH/BYT-HTTB and manufactured by Lutonix, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM VÀ THIẾT BỊ Y TẾ LONG BÌNH.
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Device Details
Registration Details
2400478ĐKLH/BYT-HTTB
17003044/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
LUTONIX 018 Drug Coated Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the popliteal artery and for the treatment of chronic total occlusions and to reduce the rate of restenosis. Additionally, the LUTONIX 018 Drug Coated Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the native arteriovenous fistula or arteriovenous graft in hemodialysis patients or for native vessels in patients with arteriovenous grafts to improve outflow and reduce the rate of restenosis. LUTONIX 018 Drug Coated Balloon Catheter is indicated for the treatment of lesions up to 290mm in length or up to approximately 7.6mg of paclitaxel per patient
Dates and Status
Apr 10, 2024