Vietnam MOH registration 2400478ĐKLH/BYT-HTTB

Peripheral blood vessel hypoxic shadow covered with paclitaxel

VN: Bóng nong mạch máu ngoại vi phủ thuốc paclitaxel

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Lutonix, Inc.·Registered Apr 10, 2024

Registration details

Analysis ID: 2400478ĐKLH/BYT-HTTB
Submission ID: 17003044/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Lutonix, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Lutonix, Inc.
Authorized Representative: CÔNG TY TNHH DƯỢC PHẨM VÀ THIẾT BỊ Y TẾ LONG BÌNH

Technical details

Intended Use: 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

Registration Date: Apr 10, 2024

About this record

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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