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AXS Catalyst Distal Access Catheter一次性使用颅内血栓抽吸导管
| Brand | Stryker（史赛克） |
|---|---|
| Manufacturer | Stryker Neurovascular史赛克神经介入 |
| Production Address | Business & Technology Park, Model Farm Road, Cork, Ireland |
| Intended Use | This product is designed to assist physicians in inserting appropriately sized interventional instruments into selected blood vessels within the neurovascular system and provide guidance during the process. It is also used for the revascularization of acute ischemic stroke patients with intracranial large vessel occlusion (internal carotid artery, middle cerebral artery – M1 and M2 segments, basilar artery, and vertebral artery) within 8 hours of symptom onset. Patients who have failed intravenous tissue-type plasminogen activator (IV t-PA) therapy are candidates for this treatment.该产品适用于辅助医师将尺寸合适的介入器械插入神经血管系统中所选的血管，并在这一过程中提供引导。同时用于在症状发作后8小时内，继发于颅内大血管闭塞（颈内动脉、大脑中动脉- M1和 M2段、基底动脉和椎动脉）的急性缺血性脑卒中患者的血运重建。不能使用静脉组织型纤溶酶原激活物(IV t-PA)或IV t-PA治疗失败的患者是该治疗的人选。 |
| References | M003IC060132A0 ……… |
| Manufacturer’s Website | https://www.strykerneurovascular.com/us/products/access/axs-catalyst-6 |
| Product Brochure | |
| Registration Certificate | 国械注进20183030224 |
Brand
Intracranial support catheter is a single-lumen catheter with a hydrophilic coating on the catheter shaft, a radiopaque marker at the distal end, and a Luer connector at the proximal end. The catheter is accompanied by a rotating hemostatic valve (RHV), a Tuohy Borst valve with side holes, and two peel-away sheaths. It is sterilized with ethylene oxide and intended for single use. The shelf life is 2 years.
颅内支持导管是一种单腔导管，导管杆具有亲水涂层，导管远端有一个不透射线标记，近端有一个鲁尔接头。导管随附一个旋转止血阀（RHV）和一个带侧孔的Tuohy Borst阀以及两个剥式导管鞘。环氧乙烷灭菌，一次性使用。货架有效期2年。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| M003IC058132A0 | 07613327012002 | 03-13-10 | AXS CATALYST 5 .058IN ID X 132CM - CE |
| M003IC060132A0 | 07613327011982 | 03-13-10 | AXS CATALYST 6 .060IN ID X 132CM - CE |
| M003IC058115A0 | 07613327011975 | 03-13-10 | AXS CATALYST 5 .058IN ID X 115CM - CE |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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