TubaVent球囊扩张系统
K号: K223542 · 2023-08-03
广告
决定日期2023-08-03
产品代码PNZ
咨询委员会医疗设备监管文本描述翻译如下：
关于[公司/产品名称]的监管信息：
- 美国食品药品监督管理局（FDA）批准号：[510(k)编号]
- 预市场批准（PMA）申请号：[PMA编号]
- 临床试验注册号（NCT）：[NCT编号]
- 医学文献标识符（PMID）：[PMID编号]
- 产品标识符：[标识符]
- 相关政策：医疗监管政策v1
- 更多信息请访问：[URL]
请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同
器械摘要
TubaVent Balloon Dilatation System is the device name listed in this FDA 510(k) record. The listed applicant is Spiggle & Theis Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223542. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TubaVent Balloon Dilatation System?
TubaVent Balloon Dilatation System is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Spiggle & Theis Medizintechnik GmbH. The 510(k) number is K223542.
When did TubaVent Balloon Dilatation System receive FDA 510(k) clearance?
TubaVent Balloon Dilatation System received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223542.
Who is the listed applicant for TubaVent Balloon Dilatation System?
The FDA 510(k) record lists Spiggle & Theis Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TubaVent Balloon Dilatation System?
The FDA product code for TubaVent Balloon Dilatation System is PNZ.
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：PNZ）
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。
K253612Acclarent AERA 鼓室管球囊扩张系统Acclarent, Inc.K230742ACCLARENT AERA 腮腺管扩张系统Acclarent, Inc.K230065VenSure™ 气球扩张系统，VenSure™ 轻型气球扩张系统，VenSure™ 导航气球扩张系统，VenSure™ ET 气球扩张系统Fiagon GmbHK220027Audion ET 扩张系统Entellus Medical, Inc.K210841NuVent 鼓室管扩张球囊Medtronic Xomed, Inc.K171761ACCLARENT AERA 腮腺管球囊扩张系统Acclarent, Inc.
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