FDA 510(k) Applications for Medical Device Product Code "JCT"
(Prosthesis, Tracheal, Expandable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K083625 | ALVEOLUS, INC | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | 03/11/2009 |
| K082284 | ALVEOLUS, INC | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | 11/20/2008 |
| K071604 | ALVEOLUS, INC | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | 09/19/2007 |
| K062511 | ALVEOLUS, INC. | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | 01/31/2007 |
| K033990 | ALVEOLUS, INC. | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | 05/12/2004 |
| K030947 | ALVEOLUS, INC. | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | 05/15/2003 |
| K032744 | ALVEOLUS, INC. | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | 11/13/2003 |
| K033053 | ALVEOLUS, INC. | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | 02/25/2004 |
| K050814 | ATRIUM MEDICAL CORP. | ATRIUM ICAST COVERED STENT | 05/06/2005 |
| K041269 | ATRIUM MEDICAL CORP. | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | 09/14/2004 |
| K031041 | BARD PERIPHERAL VASCULAR | FLUENCY TRACHEOBRONCHIAL STENT GRAFT | 06/19/2003 |
| K050832 | BARD PERIPHERAL VASCULAR, INC. | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | 07/07/2005 |
| K963241 | BOSTON SCIENTIFIC CORP. | ULTRAFLEX | 11/14/1996 |
| K121048 | BOSTON SCIENTIFIC CORP. | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | 08/03/2012 |
| K003100 | BOSTON SCIENTIFIC CORP. | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | 12/20/2000 |
| K992510 | BOSTON SCIENTIFIC CORP. | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM | 11/18/1999 |
| K141584 | Boston Scientific Corporation | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | 10/16/2014 |
| K230269 | Boston Scientific Corporation | UltraflexÖ Tracheobronchial Stent System | 07/14/2023 |
| K152842 | BOSTON SCIENTIFIC CORPORATION | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | 05/19/2016 |
| K000001 | BOSTON SCIENTIFIC SCIMED, INC. | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | 06/05/2000 |
| K021901 | BOSTON SCIENTIFIC SCIMED, INC. | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | 07/09/2002 |
| K982184 | BOSTON SCIENTIFIC SCIMED, INC. | WALLSTENT ENDOPROSTHESIS | 07/21/1998 |
| K961296 | BOSTON SCIENTIFIC SCIMED, INC. | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | 07/10/1996 |
| K964121 | BOSTON SCIENTIFIC SCIMED, INC. | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | 12/04/1996 |
| K980163 | BOSTON SCIENTIFIC SCIMED, INC. | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING | 03/13/1998 |
| K961507 | BOSTON SCIENTIFIC SCIMED, INC. | WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | 07/10/1996 |
| K140472 | ENDOCHOICE, INC. | BONASTENT TRACHEAL / BRONCHIAL | 10/17/2014 |
| K990221 | INTRATHERAPEUTICS, INC. | INTRACOIL PERIPHERAL STENT | 06/02/1999 |
| K001257 | INTRATHERAPEUTICS, INC. | INTRACOIL STENT | 05/18/2000 |
| K201342 | M.I. Tech Co., Ltd. | HANAROSTENT Trachea/Bronchium (CCC) | 12/31/2020 |
| K181200 | Merit Medical Systems, Inc | AEROmini Tracheobronchial Stent System | 09/21/2018 |
| K140382 | MERIT MEDICAL SYSTEMS, INC. | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | 11/25/2014 |
| K220424 | Micro-Tech (Nanjing) Co., Ltd. | Through the Scope Tracheal Stent System | 07/08/2022 |
| K202204 | Micro-Tech (Nanjing) Co., Ltd. | Tracheal Stent System | 09/01/2021 |
| K212403 | Micro-Tech (Nanjing) Co., Ltd. | Tracheal Stent System (Y-Shaped) | 10/30/2021 |
| K021563 | SULZER INTRATHERAPEUTICS, INC. | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | 05/31/2002 |
| K030567 | VASCULAR ARCHITECTS, INC. | MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM | 03/24/2003 |
| K031641 | VASCULAR ARCHITECTS, INC. | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM | 08/01/2003 |
| K012544 | VASCULAR ARCHITECTS, INC. | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM | 11/15/2001 |
| K023811 | W.L. GORE & ASSOCIATES,INC | MODIFICATION TO VIABAHN ENDOPROSTHESIS | 12/10/2002 |
| K013648 | W.L. GORE & ASSOCIATES,INC | VIABAHN ENDOPROSTHESIS | 01/08/2002 |
| K024178 | W.L. GORE & ASSOCIATES,INC | VIATORR ENDOPROSTHESIS | 03/07/2003 |
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