Scepter Occlusion Balloon Catheter封堵球囊导管系统

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: 1) temporary occlusion of peripheral and neurovascular vessels, balloon catheters can achieve temporary vascular occlusion, which is beneficial for blocking and controlling blood flow; 2) performing intracranial aneurysm balloon-assisted embolization procedures; 3) injecting diagnostic agents (such as contrast agents) and therapeutic agents (such as embolic materials) into peripheral vessels; 4) injecting diagnostic agents (such as contrast agents) and therapeutic agents (such as embolic materials) into neurovascular vessels that are permitted or approved for use in neurovascular procedures and are compatible with the inner diameter of the Scepter C balloon catheter.本产品用于：1)需要暂时性封堵的外周和神经血管，球囊导管可实现暂时性血管封堵，有利于对血流的阻断和控制；2)实施颅内动脉瘤球囊辅助性栓塞术；3)向外周血管输注诊断性制剂(如造影剂)和治疗性制剂(如栓塞材料)；4)向神经血管输注诊断性制剂(如造影剂)和经准许或批准用于神经血管且与Scepter C球囊导管内径相匹配的治疗性制剂(如栓塞材料)。
References	BC0415C, BC0420C, BC0410C…..
Manufacturer’s Website	https://www.microvention.com/chapla/products/scepter
Product Brochure
Registration Certificate	国械注进20143035974

Brand

This product consists of a balloon, a catheter body, and a catheter hub. The catheter body consists of a coaxial internal guide wire lumen and an external balloon inflation lumen. The balloon material is polyurethane with a platinum-iridium alloy marker band. The catheter body is made of polytetrafluoroethylene, 304V stainless steel, polyether block amide, and polyolefin. The catheter hub is made of nylon and thermoplastic elastomer. The catheter is coated with a hydrophilic coating. The product is sterilized with ethylene oxide and is for single-use only. The shelf life is three years.

本产品由球囊、管体和导管座组成，其中管体由同轴内部导丝腔和外部球囊膨胀腔构成。球囊材料为聚氨酯，标记带为铂铱合金；管体材料为聚四氟乙烯、304V不锈钢、聚醚嵌段酰胺和聚烯烃；导管座材料为尼龙和热塑性弹性体；导管涂有亲水涂层。产品经环氧乙烷灭菌，一次性使用。货架有效期三年。

Product List

REF	GTIN	Classification Code	Description
BC0411XC	00842429111055	03-13-09	封堵球囊导管系统
BC0420C	842429101995	03-13-09	封堵球囊导管系统
BC0410C	842429101971	03-13-09	封堵球囊导管系统
BC0415C	842429101988	03-13-09	封堵球囊导管系统

Risk-Based Classification风险管理类别	Class III （第三类）
Product Status产品状态	Active

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