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Name

Headway Microcatheter微导管

Brand MicroVention(美科微先)
Manufacturer MicroVention, Inc.美科微先公司
Production Address 1311 Valencia Ave. Tustin, CA 92780 USA;Zona Franca Coyol Alajuela Costa Rica;35 Enterprise Aliso Viejo, CA, 92656 USA
Intended Use This product is used for general vascular intervention, including infusion of diagnostic agents (such as contrast agents) and therapeutic devices (such as coil) in peripheral vessels, coronary arteries, and neurovascular vessels.该产品用于一般性血管内操作,包括在外周血管,冠状动脉和神经血管内输注诊断性制剂(如造影剂)和治疗性装置(如弹簧圈)。
References
Manufacturer’s Website https://www.microvention.com/chapla/products/headway
Product Brochure
Registration Certificate 国械注进20173031841

Brand

The product consists of a catheter and a shaping wire. The catheter is composed of a hub, outer wall, braided wire, marker band, inner wall lubrication coating, and outer wall hydrophilic coating. The outer wall material is Pebax and Grilamid resin, the braided wire material is 304 stainless steel, the marker band material is platinum-iridium alloy, the inner wall lubrication coating material is polytetrafluoroethylene, and the outer wall coating is a hydrophilic coating composed of Hydak B-23K and Hydak A-15. It is sterilized with ethylene oxide and for single use. The shelf life is 5 years.

该产品由导管和塑形杆组成。导管由座、外壁、编织丝、标记带、内壁润滑涂层和外壁亲水涂层组成。外壁的材料为Pebax和Grilamid树脂,编织丝的材料为304不锈钢,标记带的材料为铂铱合金,内壁润滑涂层的材料为聚四氯乙烯,外壁涂层为Hydak B-23K和HydakA-15组成的亲水涂层。环氧乙烷灭菌,一次性使用。货架有效期5年。

Product List

REFGTINClassification CodeDescription
MC17215045X0081677702764103-13-26微导管
MC17215090X0081677702765803-13-26微导管
MC172150AX0084242911073703-13-26微导管
MC172150BX0084242911074403-13-26微导管
MC172150CX0084242911075103-13-26微导管
MC172150DX0084242911076803-13-26微导管
MC172150JX0081677702766503-13-26微导管
MC172150S0081677702762703-13-26微导管
MC172150STX0084242911072003-13-26微导管
MC172150SX0081677702763403-13-26微导管
MC172150WX0084242911077503-13-26微导管
MC212150S0081677702767203-13-26微导管
MC212156S0084242911601203-13-26微导管
MC272150S0081677702768903-13-26微导管
MC272156S0084242911602903-13-26微导管
Risk-Based Classification风险管理类别

Product Status产品状态

Active

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