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SOFIA Distal Access Catheter远端通路导管

Brand MicroVention(美科微先)
Manufacturer MicroVention, Inc.美科微先公司
Production Address 1. 1311 Valencia Ave. Tustin, CA 92780, USA;2. Zona Franca Coyol Alajuela Costa Rica3. 35 Enterprise, Aliso Viejo, CA 92656, USA
Intended Use This product is suitable for general intravascular use, including neurovascular and peripheral vascular systems; it assists in the introduction of diagnostic or therapeutic devices; it is not suitable for coronary arteries.该产品适用于一般性血管内使用,包括神经血管和外周血管系统;有助于导入诊断性或治疗装置;不适用于冠状动脉。
References DA5125ST,DA6125ST……..
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20193030007


The product is a non-conical single-lumen catheter, with the catheter inner wall made of polytetrafluoroethylene and polyolefin, and the catheter body made of stainless steel coil and braided silk double-layer composite structure. The catheter outer wall material is polyurethane, PEBAX, and polyamide, with a hydrophilic coating on the outer surface. The distal end of some models has steam plasticity and non-radiopaque markers. The hydrophilic coating materials are Hydak B-23K and Hydak A-15. The packaging also includes an accessory introducer sheath, and some models come with a steam molding rod. Ethylene oxide sterilization, for single use. The shelf life is three years.

该产品是一种非锥形的单腔导管,导管内壁材料为聚四氟乙烯和聚烯烃,管身使用不锈钢线圈和编织丝双层复合结构,导管外壁材料为聚氨酯,PEBAX和聚酰胺,外表面带有亲水涂层。部分型号规格的远端具有蒸汽可塑性,并带有不透射线标记。亲水涂层材料为Hydak B-23K和Hydak A-15。包装内还有附件导入鞘管,部分型号规格配有蒸汽塑形杆。环氧乙烷灭菌,一次性使用。货架有效期三年。

Product List

REFGTINClassification CodeDescription
Risk-Based Classification风险管理类别

Product Status产品状态



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