FDA 510(k)

SpaceOAR System

K号: K202224 · 2020-08-28

决定日期2020-08-28

产品代码OVB

咨询委员会RA

决定实质等同

器械摘要

SpaceOAR 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 2020-08-28 under 510(k) number K202224. 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 System?

SpaceOAR System is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Boston Scientific Corporation. The 510(k) number is K202224.

When did SpaceOAR System receive FDA 510(k) clearance?

SpaceOAR System received FDA 510(k) clearance on 2020-08-28, under 510(k) number K202224.

Who is the listed applicant for SpaceOAR 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 SpaceOAR System?

The FDA product code for SpaceOAR System 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。

K262151SpaceOAR Flex™ 系统 K261153LithoVue Elite 数字柔性输尿管镜系统 K261915Navigator™ Flex 肾盂输尿管通路鞘套装 K262165FARADRIVE™ 导向鞘（M004PF21M402）K262462TheraSphere 360® Y-90管理平台 K261488OBSIDIO 可变形栓塞

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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。