FDA 510(k)

AXS Lift 颅内基底导管

K号: K253032 · 2026-02-11

决定日期2026-02-11

产品代码QJP

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

AXS Lift Intracranial Base Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K253032. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AXS Lift Intracranial Base Catheter?

AXS Lift Intracranial Base Catheter is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Stryker Neurovascular. The 510(k) number is K253032.

When did AXS Lift Intracranial Base Catheter receive FDA 510(k) clearance?

AXS Lift Intracranial Base Catheter received FDA 510(k) clearance on 2026-02-11, under 510(k) number K253032.

Who is the listed applicant for AXS Lift Intracranial Base Catheter?

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 AXS Lift Intracranial Base Catheter?

The FDA product code for AXS Lift Intracranial Base Catheter is QJP.

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 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 K241637Echo 颅内基底导管

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。