Vietnam MOH registration 2402018ĐKLH/BYT-HTTB

Mural Occlusion by Straight Intracranial Aneurysm

VN: Bóng tắc mạch chẹn cổ túi phình mạch não thẳng

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Micro Therapeutics, Inc. DBA ev3 Neurovascular·Registered Aug 27, 2024

Registration details

Analysis ID: 2402018ĐKLH/BYT-HTTB
Submission ID: 17002597/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Micro Therapeutics, Inc. DBA ev3 Neurovascular
Manufacturer Country: Theo theo phụ lục
Product Owner: Micro Therapeutics, Inc. DBA ev3 Neurovascular
Authorized Representative: CÔNG TY TNHH MEDTRONIC VIỆT NAM

Technical details

Intended Use: The intraluminal occlusion balloons, which are used in peripheral blood vessels and in the cerebral arteries, are indicated for temporary occlusion of selected vascular positions. These balloons provide a selective technique for temporary occlusion of blood vessels, which is useful for stopping or controlling selective blood flow; intraluminal occlusion balloons may also be used in the treatment of intracranial aneurysms that require balloon support and in the treatment of vasospasm.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Mural Occlusion by Straight Intracranial Aneurysm 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 2402018ĐKLH/BYT-HTTB and manufactured by Micro Therapeutics, Inc. DBA ev3 Neurovascular. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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