FDA 510(k)

Trevo XP ProVue 抓取器和 Trevo NXT™ ProVue 抓取器

K号: K203219 · 2020-12-29

决定日期2020-12-29

产品代码POL

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决定实质等同

器械摘要

Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2020-12-29 under 510(k) number K203219. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever?

Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever is a medical device that received FDA 510(k) clearance on 2020-12-29. The listed applicant is Stryker Neurovascular. The 510(k) number is K203219.

When did Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever receive FDA 510(k) clearance?

Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever received FDA 510(k) clearance on 2020-12-29, under 510(k) number K203219.

Who is the listed applicant for Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever?

The FDA 510(k) record lists Stryker Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever?

The FDA product code for Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever is POL.

列明Stryker Neurovascular为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261889Trevo Trak 21 微导管 K253032AXS Lift 颅内基底导管 K252694目标可拆卸线圈 K251832InZone IST 分离系统；IZDS 连接电缆 K242289Excelsior XT-27 微导管，Excelsior XT-27 Flex 微导管，Excelsior XT-27 预成型微导管，Excelsior XT-27 Flex 预成型微导管 K243593AXS Lift 颅内基底导管

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