JCT · Prosthesis, Tracheal, Expandable
General, Plastic Surgery · 21 CFR 878.3720 · Class 2
Overview
| Product Code | JCT |
|---|---|
| Device Name | Prosthesis, Tracheal, Expandable |
| Regulation | 21 CFR 878.3720 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | Ultraflex Tracheobronchial Stent System | Boston Scientific Corporation | Jul 14, 2023 | SESE |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | Jul 8, 2022 | SESE |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | Oct 30, 2021 | SESE |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | Sep 1, 2021 | SESE |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | Dec 31, 2020 | SESE |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | Sep 21, 2018 | SESE |
| K152842 | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | Boston Scientific Corporation | May 19, 2016 | SESE |
| K140382 | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | Merit Medical Systems, Inc. | Nov 25, 2014 | SESE |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | Oct 17, 2014 | SESE |
| K141584 | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | Boston Scientific Corporation | Oct 16, 2014 | SESE |
| K121048 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | Aug 3, 2012 | SESE |
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | Mar 11, 2009 | SESU |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Alveolus, Inc. | Nov 20, 2008 | SESU |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | Sep 19, 2007 | SESU |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Alveolus, Inc. | Jan 31, 2007 | SESU |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | Jul 7, 2005 | SESE |
| K050814 | ATRIUM ICAST COVERED STENT | Atrium Medical Corp. | May 6, 2005 | SESE |
| K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | Atrium Medical Corp. | Sep 14, 2004 | SESE |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | May 12, 2004 | SESE |
| K033053 | 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
