FDA 510(k)

Ultraflex™ 气管支气管支架系统

K号: K230269 · 2023-07-14

决定日期2023-07-14

产品代码JCT

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决定实质等同

器械摘要

Ultraflex™ Tracheobronchial Stent System 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 2023-07-14 under 510(k) number K230269. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultraflex™ Tracheobronchial Stent System?

Ultraflex™ Tracheobronchial Stent System is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Boston Scientific Corporation. The 510(k) number is K230269.

When did Ultraflex™ Tracheobronchial Stent System receive FDA 510(k) clearance?

Ultraflex™ Tracheobronchial Stent System received FDA 510(k) clearance on 2023-07-14, under 510(k) number K230269.

Who is the listed applicant for Ultraflex™ Tracheobronchial Stent System?

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 Ultraflex™ Tracheobronchial Stent System?

The FDA product code for Ultraflex™ Tracheobronchial Stent System is JCT.

列明Boston Scientific Corporation为申报人的其他记录

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