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Name

EverCross .035″ OTW PTA Dilatation CatheterPTA扩张导管

Brand EV3(医伟司安)
Manufacturer 医伟司安股份有限公司ev3, Inc.
Production Address 4600 Nathan Lane North, Plymouth, MN, 55442, United States
Intended Use This product is used for the dilation of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infrapopliteal artery, and renal artery stenosis, and for the treatment of occlusive injuries in autogenous or prosthetic arteriovenous dialysis fistulas. It is also suitable for post-stent dilation of the peripheral vascular system.该产品用于扩张髂动脉、股动脉、髂股动脉、腘动脉、下腘动脉和肾动脉的狭窄,并用于治疗自体或人工动静脉透析瘘的堵塞性损伤。该产品还适用于周围脉管系统的支架后扩张。
References AB35W12060135……
Manufacturer’s Website https://global.medtronic.com/xg-en/healthcare-professionals/products/cardiovascular/pta-balloons/evercross.html
Product Brochure
Registration Certificate 国械注进20173031834

Brand

This product is used for the dilation of the iliac artery, femoral artery, iliofemoral artery, popliteal artery, infrapopliteal artery, and renal artery stenosis, and for the treatment of occlusive injuries in autogenous or prosthetic arteriovenous dialysis fistulas. It is also suitable for post-stent dilation of the peripheral vascular system.

该产品为一套PTA扩张导管,球囊的材料为聚酰胺,导管的材料为聚酰胺和聚醚嵌段酰胺。亲水涂层的材料为光敏磺酸钠盐和聚乙烯吡咯烷酮。产品经环氧乙烷灭菌,货架有效期为3年,一次性使用。

Product List

REFGTINClassification CodeDescription
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Risk-Based Classification风险管理类别

Product Status产品状态

Inactive

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