FDA 510(k)

AXIOS支架和电凝增强输送系统

K号: K220112 · 2022-09-07

决定日期2022-09-07

产品代码PCU

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决定实质等同

器械摘要

AXIOS Stent and Electrocautery-Enhanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K220112. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AXIOS Stent and Electrocautery-Enhanced Delivery System?

AXIOS Stent and Electrocautery-Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Boston Scientific Corporation. The 510(k) number is K220112.

When did AXIOS Stent and Electrocautery-Enhanced Delivery System receive FDA 510(k) clearance?

AXIOS Stent and Electrocautery-Enhanced Delivery System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K220112.

Who is the listed applicant for AXIOS Stent and Electrocautery-Enhanced Delivery System?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for AXIOS Stent and Electrocautery-Enhanced Delivery System?

The FDA product code for AXIOS Stent and Electrocautery-Enhanced Delivery System is PCU.

列明Boston Scientific Corporation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。

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