VisionAir 患者专用气道支架
K号: K213969 · 2022-10-07
广告
决定日期2022-10-07
产品代码NWA
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
VisionAir Patient-Specific Airway Stent is the device name listed in this FDA 510(k) record. The listed applicant is New Cos Inc. Dba Visionair Solutions. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K213969. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VisionAir Patient-Specific Airway Stent?
VisionAir Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is New Cos Inc. Dba Visionair Solutions. The 510(k) number is K213969.
When did VisionAir Patient-Specific Airway Stent receive FDA 510(k) clearance?
VisionAir Patient-Specific Airway Stent received FDA 510(k) clearance on 2022-10-07, under 510(k) number K213969.
Who is the listed applicant for VisionAir Patient-Specific Airway Stent?
The FDA 510(k) record lists New Cos Inc. Dba Visionair Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisionAir Patient-Specific Airway Stent?
The FDA product code for VisionAir Patient-Specific Airway Stent is NWA.
相关临床试验
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。
相关器械（代码：NWA）
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。
广告