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Name

SOLITAIRE™ AB-Neurovascular Remodeling Device颅内血管支架

Brand EV3(医伟司安)
Manufacturer Micro Therapeutics Inc. DBA ev3 Neurovascular麦克罗医伟司安神经血管医疗股份有限公司
Production Address 9775 Toledo Way, Irvine, CA 92618 United States America
Intended Use Used for the treatment of intracranial neurovascular diseases, and used together with embolic devices for the treatment of intracranial aneurysms.适用于治疗颅内神经血管疾病,与栓塞装置一起用于治疗颅内动脉瘤。
References SAB-4-20, SAB-6-30 ……
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20173136562

Brand

The product consists of a stent, a protective sheath, and a detachable push wire. The main material of the stent is a nickel-titanium alloy, and the radiopaque marker material is a platinum-iridium alloy. Ethylene oxide sterilization, for single-use only. The product has a shelf life of 2 years.

该产品由支架、保护套和可电解脱的推送金属丝组成。支架主体材料为镍钛合金,不透射线显影点材料为铂铱合金。环氧乙烷灭菌,产品一次性使用。产品有效期2年。

Products List

REFGTINClassification CodeDescription
SAB-4-150084753601839613-06-06SAB-4-15 颅内血管支架
SAB-4-150084753601982913-06-06SAB-4-15 颅内血管支架
SAB-4-200084753601984313-06-06SAB-4-20 颅内血管支架
SAB-4-200084753601841913-06-06SAB-4-20 颅内血管支架
SAB-6-200084753601986713-06-06SAB-6-20 颅内血管支架
SAB-6-200084753601843313-06-06SAB-6-20 颅内血管支架
SAB-6-300084753601988113-06-06SAB-6-30 颅内血管支架
SAB-6-300084753601845713-06-06SAB-6-30 颅内血管支架
Risk-Based Classification风险管理类别

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