FDA 510(k)

SpyGlass Discover球囊扩张导管

K号: K212582 · 2022-05-06

决定日期2022-05-06

产品代码GCA

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决定实质等同

器械摘要

SpyGlass Discover Balloon Dilation Catheter 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 2022-05-06 under 510(k) number K212582. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpyGlass Discover Balloon Dilation Catheter?

SpyGlass Discover Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Boston Scientific Corporation. The 510(k) number is K212582.

When did SpyGlass Discover Balloon Dilation Catheter receive FDA 510(k) clearance?

SpyGlass Discover Balloon Dilation Catheter received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212582.

Who is the listed applicant for SpyGlass Discover Balloon Dilation Catheter?

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 SpyGlass Discover Balloon Dilation Catheter?

The FDA product code for SpyGlass Discover Balloon Dilation Catheter is GCA.

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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相关器械（代码：GCA）

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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