Product code JCT
- Device name
- Prosthesis, Tracheal, Expandable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3720
- Review panel
- AN
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | 2023-07-14 |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-08 |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | 2021-10-30 |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021-09-01 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020-12-31 |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | 2018-09-21 |
| K152842 | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | Boston Scientific Corporation | 2016-05-19 |
| K140382 | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | Merit Medical Systems, Inc. | 2014-11-25 |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | 2014-10-17 |
| K141584 | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | Boston Scientific Corporation | 2014-10-16 |
| K121048 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | 2012-08-03 |
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2009-03-11 |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Alveolus, Inc. | 2008-11-20 |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2007-09-19 |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Alveolus, Inc. | 2007-01-31 |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | 2005-07-07 |
| K050814 | ATRIUM ICAST COVERED STENT | Atrium Medical Corp. | 2005-05-06 |
| K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | Atrium Medical Corp. | 2004-09-14 |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2004-05-12 |
| K033053 | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2004-02-25 |
| K032744 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2003-11-13 |
| K031641 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM | Vascular Architects, Inc. | 2003-08-01 |
| K031041 | FLUENCY TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular | 2003-06-19 |
| K030947 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2003-05-15 |
| K030567 | MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM | Vascular Architects, Inc. | 2003-03-24 |
| K024178 | VIATORR ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2003-03-07 |
| K023811 | MODIFICATION TO VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-12-10 |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | 2002-07-09 |
| K021563 | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | Sulzer Intratherapeutics, Inc. | 2002-05-31 |
| K013648 | VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-01-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729204428 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283331 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283324 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283317 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283300 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283294 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283287 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283270 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283263 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729283256 | WALLGRAFT® | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204688 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204664 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204657 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204640 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204633 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204060 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204411 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204404 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204398 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204176 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204169 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204152 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204145 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204138 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204121 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204114 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204107 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204091 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204084 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204077 | WALLSTENT® Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |