Myocardial ischemia
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Translumina GmbH·Registered Nov 06, 2024- Analysis ID
- 2403312ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211220-0006
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Translumina GmbH
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Translumina GmbH
- Authorized Representative
- CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM
- Intended Use
- - The Cathy No 4 catheter system is indicated for dilatation and thermal expansion at the site of the stenosis of the coronary artery or the bridging artery in the case of a narrowed coronary artery or the anterior or posterior tibial artery of the lower limb, with the maximum length of the lesion being 45 mm. - The perforation of the vessel can be improved by the deployment of the balloon - Patients considered for balloon dilatation should be considered suitable candidates for such indication.
- Registration Date
- Nov 06, 2024
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Access comprehensive regulatory information for Myocardial ischemia 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 2403312ĐKLH/BYT-HTTB and manufactured by Translumina GmbH. The authorized representative in Vietnam is CÔNG TY TNHH IDS MEDICAL SYSTEMS VIỆT NAM.
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