FDA 510(k)

SpaceOAR Vue 系统 (SV-2101)

K号: K260119 · 2026-02-10

决定日期2026-02-10

产品代码OVB

咨询委员会RA

决定实质等同

器械摘要

SpaceOAR Vue System (SV-2101) 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 2026-02-10 under 510(k) number K260119. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpaceOAR Vue System (SV-2101)?

SpaceOAR Vue System (SV-2101) is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260119.

When did SpaceOAR Vue System (SV-2101) receive FDA 510(k) clearance?

SpaceOAR Vue System (SV-2101) received FDA 510(k) clearance on 2026-02-10, under 510(k) number K260119.

Who is the listed applicant for SpaceOAR Vue System (SV-2101)?

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 SpaceOAR Vue System (SV-2101)?

The FDA product code for SpaceOAR Vue System (SV-2101) is OVB.

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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官方来源

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