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Name

HydroCoil Embolic System with V-Trak Delivery System栓塞弹簧圈

Brand MicroVention(美科微先)
Manufacturer MicroVention, Inc.美科微先公司
Production Address 35 Enterprise Aliso Viejo, CA 92656 USA和Zona Franca Coyol Alajuela Costa Rica
Intended Use This product is used for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulas. It can also be used to occlude blood vessels in the neurovascular system to permanently block blood flow to an aneurysm or other vascular malformations, and to perform embolization procedures on the peripheral vascular system.该产品用于对颅内动脉瘤和诸如动静脉畸形和动静脉瘘等其他神经血管异常实施血管内栓塞术。还可以用于阻塞神经血管系统的血管,藉以永久性地阻断流向动脉瘤或其他血管畸形处的血流及对外周血管系统的动静脉实施栓塞术治疗。
References …..
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20173136992

Brand

This product consists of plastic coil, spring coil, introducer sheath, retractable lock, and delivery pusher. The material of the spring coil wire is platinum tungsten alloy, with a gel core and an anti-rotation wire made of polyolefin elastomer. The material of the coupler between the delivery pusher is platinum iridium alloy. The product is sterilized by electron beam and is for single-use only, with a shelf life of 5 years.

该产品由塑料盘管、弹簧圈、导入鞘管、缩退锁和递送推杆组成。弹簧圈丝体的材料为铂钨合金,内有凝胶芯以及聚烯烃弹性体制成的抗解旋丝,与递送推杆间的耦合器的材料为铂依合金。电子束灭菌,产品一次性使用,货架有效期5年。

Prodcut List

REFGTINClassification CodeDescription
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Risk-Based Classification风险管理类别

Product Status产品状态

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