Taiwan FDA registration 8fd90b23df90a48feae7f81918d1b504
"Trock" Lannith thoracic aortic aneurysm stent delivery guidance system
TW: “曲克”蘭尼思胸主動脈瘤支架暨輸送導引系統
Taiwan·Risk Class 3·WILLIAM COOK EUROPE APS·Registered Nov 09, 2009 – Nov 09, 2019CancelledRegistration details
- Analysis ID
- 8fd90b23df90a48feae7f81918d1b504
- Customs Code
- DHA00602040906
Company information
- Manufacturer
- WILLIAM COOK EUROPE APS
- Manufacturer Country
- Denmark
- Authorized Representative
- COOK TAIWAN LIMITED
Product details
- Intended Use
- It is suitable for endovascular repair treatment of patients with descending aortic aneurysm. It is designed to treat patients with atherosclerotic aneurysms, symptomatic acute or chronic dissecting aneurysms, aneurysms containing ruptured, growing aneurysms and/or resulting ischemia. Aortic vascular morphologies that are suitable for endovascular repair include: Appropriate femoral/iliac artery access, compatible with the desired delivery system, ? Along the full length of the treated aorta, the radius of curvature greater than 35mm,? Aneurysm-free segments (fixed site) proximal and distal to the aortic aneurysm: 1.) Length at least 20mm 2.) The measured diameter from outer wall to outer wall is not more than 38mm and not less than 20mm, and 3.) The angle is less than 45 degrees.
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E.0001 Cardiovascular stents
- Import Information
- import
Dates and status
- Registration Date
- Nov 09, 2009
- Expiry Date
- Nov 09, 2019
- Cancellation Date
- Jun 16, 2022
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Trock" Lannith thoracic aortic aneurysm stent delivery guidance system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8fd90b23df90a48feae7f81918d1b504 and manufactured by WILLIAM COOK EUROPE APS. The authorized representative in Taiwan is COOK TAIWAN LIMITED.
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