Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720) → JCT — Prosthesis, Tracheal, Expandable # JCT · Prosthesis, Tracheal, Expandable _General, Plastic Surgery · 21 CFR 878.3720 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT ## Overview - **Product Code:** JCT - **Device Name:** Prosthesis, Tracheal, Expandable - **Regulation:** [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **Implant:** yes - **Life-sustaining:** yes ## Identification The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system. ## Classification Rationale Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.” ## Special Controls The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.” ## Recent Cleared Devices (20 of 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230269](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K230269.md) | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | Jul 14, 2023 | SESE | | [K220424](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K220424.md) | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | Jul 8, 2022 | SESE | | [K212403](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K212403.md) | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | Oct 30, 2021 | SESE | | [K202204](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K202204.md) | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | Sep 1, 2021 | SESE | | [K201342](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K201342.md) | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | Dec 31, 2020 | SESE | | [K181200](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K181200.md) | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | Sep 21, 2018 | SESE | | [K152842](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K152842.md) | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | Boston Scientific Corporation | May 19, 2016 | SESE | | [K140382](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K140382.md) | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | Merit Medical Systems, Inc. | Nov 25, 2014 | SESE | | [K140472](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K140472.md) | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | Oct 17, 2014 | SESE | | [K141584](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K141584.md) | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | Boston Scientific Corporation | Oct 16, 2014 | SESE | | [K121048](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K121048.md) | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | Aug 3, 2012 | SESE | | [K083625](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K083625.md) | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | Mar 11, 2009 | SESU | | [K082284](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K082284.md) | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Alveolus, Inc. | Nov 20, 2008 | SESU | | [K071604](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K071604.md) | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | Sep 19, 2007 | SESU | | [K062511](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K062511.md) | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Alveolus, Inc. | Jan 31, 2007 | SESU | | [K050832](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K050832.md) | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | Jul 7, 2005 | SESE | | [K050814](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K050814.md) | ATRIUM ICAST COVERED STENT | Atrium Medical Corp. | May 6, 2005 | SESE | | [K041269](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K041269.md) | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | Atrium Medical Corp. | Sep 14, 2004 | SESE | | [K033990](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K033990.md) | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | May 12, 2004 | SESE | | [K033053](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K033053.md) | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | Feb 25, 2004 | SESE | ## Top Applicants - Boston Scientific Scimed, Inc. — 9 clearances - Alveolus, Inc. — 8 clearances - Boston Scientific Corp — 4 clearances - W. L. Gore & Associates, Inc. — 3 clearances - Vascular Architects, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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