FDA 510(k)

Ultraflex Tracheobronchial Stent System

K-Number: K230269 · 2023-07-14

Decision Date2023-07-14

Product CodeJCT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ultraflex Tracheobronchial Stent System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-07-14 under approval number K230269. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K230269.

When was Ultraflex Tracheobronchial Stent System approved by the FDA?

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

What company makes Ultraflex Tracheobronchial Stent System?

Ultraflex Tracheobronchial Stent System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Ultraflex Tracheobronchial Stent System?

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

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Related Devices (Code: JCT)

K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc. K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd. K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.