FDA 510(k)

Syntheon LAA排除系统，Syntheon LAA选择指南

K号: K220305 · 2022-10-28

决定日期2022-10-28

产品代码PZX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K220305. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Syntheon. The 510(k) number is K220305.

When did Syntheon LAA Exclusion System, Syntheon LAA Selection Guide receive FDA 510(k) clearance?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide received FDA 510(k) clearance on 2022-10-28, under 510(k) number K220305.

Who is the listed applicant for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

The FDA 510(k) record lists Syntheon as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

The FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is PZX.

相关器械（代码：PZX）

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。

官方来源

在 FDA 数据库中查看 →

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。

器械摘要

常见问题

相关临床试验

相关器械（代码：PZX）

官方来源