FDA 510(k)

虎猎者17超再血管化装置

K号: K251603 · 2025-10-06

决定日期2025-10-06

产品代码NRY

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

Tigertriever 17 Ultra Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Medical Ltd.. It received FDA 510(k) clearance on 2025-10-06 under 510(k) number K251603. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tigertriever 17 Ultra Revascularization Device?

Tigertriever 17 Ultra Revascularization Device is a medical device that received FDA 510(k) clearance on 2025-10-06. The listed applicant is Rapid Medical Ltd.. The 510(k) number is K251603.

When did Tigertriever 17 Ultra Revascularization Device receive FDA 510(k) clearance?

Tigertriever 17 Ultra Revascularization Device received FDA 510(k) clearance on 2025-10-06, under 510(k) number K251603.

Who is the listed applicant for Tigertriever 17 Ultra Revascularization Device?

FDA 510(k)记录中列出Rapid Medical Ltd.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Tigertriever 17 Ultra Revascularization Device?

The FDA product code for Tigertriever 17 Ultra Revascularization Device is NRY.

列明Rapid Medical Ltd.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。

K253146超驱动 35 导丝 K260617虎猎者13超再血管化装置 K254006Drivewire 35 导丝 K253062老虎追捕者25血管重建装置 K233791Drivewire 24 导丝 K230429老虎追捕者21再血管化装置，老虎追捕者17再血管化装置，老虎追捕者13再血管化装置

查看所有 10 个设备 →

官方来源

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