Taiwan FDA registration 9dcec3b701653f47d454910ad7fc622c
"Caudix" Pross Pronickel Titanium Bracket System
TW: “考迪斯”普賽斯普羅鎳鈦支架系統
Taiwan·Risk Class 3·Cordis US Corp.;; Cardinal Health Mexico 244 S. de R.L. de C.V.·Registered Oct 12, 2022 – Sep 07, 2025ExpiredRegistration details
- Analysis ID
- 9dcec3b701653f47d454910ad7fc622c
- Customs Code
- DHA00602143400
Company information
- Manufacturer Country
- Mexico;;United States
- Authorized Representative
- EMERGO TAIWAN LIMITED
Product details
- Intended Use
- The Cordis Precise PRO RX Nitinol Stent System is used in conjunction with the Cordis ANGIOGUARD RX Embolic Capture Guide System and is suitable for the treatment of patients who must undergo carotid vascular repair and carotid endarterectomy may cause adverse reactions, and must meet the following conditions: 1. Have neurological symptoms and are diagnosed with total carotid artery or internal carotid artery stenosis by ultrasound or angiography ≥ 50% 80% of patients, or no neurological symptoms, but diagnosed with total carotid artery or internal carotid artery stenosis by ultrasound or angiography≥ and 2. The diameter of the blood vessel of the patient's target lesion must be 4-9mm. THE TARGET LESION MUST BE BETWEEN 3 MM AND 7.5 MM FROM THE END OF THE VESSEL TO INSERT THE ANGIOGUARD RX EMBOLIC CAPTURE GUIDE.
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E.0001 Cardiovascular stents
- Import Information
- import
Dates and status
- Registration Date
- Oct 12, 2022
- Expiry Date
- Sep 07, 2025
About this record
Access comprehensive regulatory information for "Caudix" Pross Pronickel Titanium Bracket System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 9dcec3b701653f47d454910ad7fc622c and manufactured by Cordis US Corp.;; Cardinal Health Mexico 244 S. de R.L. de C.V.. The authorized representative in Taiwan is EMERGO TAIWAN LIMITED.
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