Headway Duo Microcatheter微导管

Brand	MicroVention(美科微先)
Manufacturer	MicroVention, Inc.美科微先公司
Production Address	1）1311 Valencia Avenue. Tustin, California 92780 2）Zona Franca Coyol Alajuela Costa Rica 3) 35 Enterprise Aliso Viejo, CA, 92656 USA
Intended Use	This product is suitable for general vascular procedures, including the administration of diagnostic agents (such as contrast media) and therapeutic agents (such as embolic materials) in peripheral and coronary arteries. This product is also suitable for neurovascular procedures, for the administration of diagnostic agents (such as contrast media) and therapeutic agents that are permitted or approved for use in neurovasculature and compatible with the microcatheter inner diameter.该产品适用于一般性血管内操作，包括在外周和冠状动脉血管中输注诊断性制剂（如造影剂）和治疗性制剂（如栓塞材料）。该产品还适用于神经血管内操作，用于经准许或者批准用于神经血管中且与微导管内径相容的诊断性制剂（如造影剂）和治疗性制剂输注。
References	MC162156S、 MC162167S
Manufacturer’s Website	https://www.microvention.com/chapla/products/headway
Product Brochure
Registration Certificate	国械注进20163030331

Brand

The product consists of a catheter, shaping wire, and introducer sheath. The catheter is composed of a catheter body, adhesive, coil, braided wire, hub (Luer connector), and hub-to-body connection with a marker band and a hydrophilic coating. The catheter’s outer wall is made of PEBAX and nylon, while the inner wall is made of polyvinyl chloride. The adhesive is a UV-curable adhesive called Dymax. The coil and braided wire are made of stainless steel, and the hub (Luer connector) is made of nylon. The hub-to-body connection is made of PEBAX. The marker band is made of platinum/iridium alloy, and the hydrophilic coating is made of Hydak B-23K and Hydak A-15. The introducer sheath is made of PEBAX. The shaping wire is made of 304 stainless steel. The product is sterilized with ethylene oxide, for single-use only, and has a shelf life of 3 years.

该产品由导管、塑形杆和导入鞘管组成。导管由管体、粘合剂、线圈、编织丝、座（鲁尔接头）、座与管体连接部分组成，带有标记带，并涂覆亲水涂层；管体外壁采用PEBAX和尼龙制造，管体内壁采用聚四氯乙烯制造；粘合剂为紫外光固化粘合剂Dymax;线圈和编织丝采用不锈钢制造，座（鲁尔接头）采用尼龙制造；座与管体连接部分采用PEBAX制造；标记带采用铂/铱合金制造；亲水涂层由Hydak B-23K和Hydak A-15制成。导入鞘管采用PEBAX制造。塑形杆由304不锈钢制造。环氧乙烷灭菌，一次性使用，货架有效期3年。