FDA 510(k)

AXIOS支架和电凝增强输送系统

K号: K203132 · 2021-04-15

决定日期2021-04-15

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 2021-04-15 under 510(k) number K203132. 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 2021-04-15. The listed applicant is Boston Scientific Corporation. The 510(k) number is K203132.

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 2021-04-15, under 510(k) number K203132.

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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