FDA 510(k)

TruDi 导航系统

K号: K192397 · 2020-01-30

决定日期2020-01-30

产品代码PGW

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决定实质等同

器械摘要

TruDi Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K192397. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TruDi Navigation System?

TruDi Navigation System is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Biosense Webster. The 510(k) number is K192397.

When did TruDi Navigation System receive FDA 510(k) clearance?

TruDi Navigation System received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192397.

Who is the listed applicant for TruDi Navigation System?

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

What is the FDA product code for TruDi Navigation System?

The FDA product code for TruDi Navigation System is PGW.

列明Biosense Webster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。

K161701CARTO ENT 系统

相关器械（代码：PGW）

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。

K262235ApexCut™ 自动电磁跟踪刀片（187BL4012EM）；ApexCut™ 自动电磁跟踪刀片（187BL4040EM）；ApexCut™ 自动电磁跟踪刀片（187BL4060EM）；ApexCut™ 自动电磁跟踪刀片（187BL2975EM）；ApexCut™ 自动电磁跟踪刀片（187BL3590EM）；ApexCut™ 自动电磁跟踪刀片（187BL4000LEM）Medtronic Xomed, Inc.K261540Cube 4D 导航系统，VirtuEye ProFiagon GmbH K253395Stealth AXiS™ ENT临床应用Medtronic Navigation, Inc.K243053Navient 图像引导导航系统 (ENT) (955-NC-NC)Claronav K231862TruDi® 导航系统 V3（FG-2000-00）Acclarent, Inc.K223734ENT EMBrainlab AG

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