FDA 510(k)

InZone IST 分离系统；IZDS 连接电缆

K号: K251832 · 2025-10-17

决定日期2025-10-17

产品代码HCG

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决定实质等同

器械摘要

InZone IST Detachment System; IZDS Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251832. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InZone IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Stryker Neurovascular. The 510(k) number is K251832.

When did InZone IST Detachment System; IZDS Connecting Cable receive FDA 510(k) clearance?

InZone IST Detachment System; IZDS Connecting Cable received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251832.

Who is the listed applicant for InZone IST Detachment System; IZDS Connecting Cable?

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 InZone IST Detachment System; IZDS Connecting Cable?

The FDA product code for InZone IST Detachment System; IZDS Connecting Cable is HCG.

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 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 K241637Echo 颅内基底导管

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相关器械（代码：HCG）

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。

官方来源

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