FDA Product Code
FDA Product Code JCT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3720
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230269 | Ultraflex Tracheobronchial Stent System | Boston Scientific Corporation | 2023-07-14 | Special | PDF ↗ |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-08 | Traditional | PDF ↗ |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | 2021-10-30 | Traditional | PDF ↗ |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021-09-01 | Traditional | PDF ↗ |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020-12-31 | Traditional | PDF ↗ |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | 2018-09-21 | Traditional | PDF ↗ |
| K152842 | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | Boston Scientific Corporation | 2016-05-19 | Traditional | PDF ↗ |
| K140382 | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | Merit Medical Systems, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | 2014-10-17 | Traditional | PDF ↗ |
| K141584 | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | Boston Scientific Corporation | 2014-10-16 | Traditional | PDF ↗ |
| K121048 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | 2012-08-03 | Traditional | PDF ↗ |
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2009-03-11 | Traditional | PDF ↗ |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Alveolus, Inc. | 2008-11-20 | Traditional | PDF ↗ |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Alveolus, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | 2005-07-07 | Special | PDF ↗ |
| K050814 | ATRIUM ICAST COVERED STENT | Atrium Medical Corp. | 2005-05-06 | Special | PDF ↗ |
| K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | Atrium Medical Corp. | 2004-09-14 | Traditional | PDF ↗ |
| K033990 | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2004-05-12 | Special | PDF ↗ |
| K033053 | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K032744 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2003-11-13 | Traditional | PDF ↗ |
| K031641 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM | Vascular Architects, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031041 | FLUENCY TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular | 2003-06-19 | Abbreviated | PDF ↗ |
| K030947 | ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2003-05-15 | Traditional | PDF ↗ |
| K030567 | MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM | Vascular Architects, Inc. | 2003-03-24 | Special | PDF ↗ |
| K024178 | VIATORR ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K023811 | MODIFICATION TO VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-12-10 | Special | PDF ↗ |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | 2002-07-09 | Special | PDF ↗ |
| K021563 | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | Sulzer Intratherapeutics, Inc. | 2002-05-31 | Special | PDF ↗ |
| K013648 | VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K012544 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM | Vascular Architects, Inc. | 2001-11-15 | Traditional | PDF ↗ |
| K003100 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | 2000-12-20 | Traditional | PDF ↗ |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | 2000-06-05 | Traditional | PDF ↗ |
| K001257 | INTRACOIL STENT | Intratherapeutics, Inc. | 2000-05-18 | Special | PDF ↗ |
| K992510 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM | Boston Scientific Corp | 1999-11-18 | Traditional | PDF ↗ |
| K990221 | INTRACOIL PERIPHERAL STENT | Intratherapeutics, Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K982184 | WALLSTENT ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-07-21 | Special | PDF ↗ |
| K980163 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING | Boston Scientific Scimed, Inc. | 1998-03-13 | Traditional | PDF ↗ |
| K964121 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K963241 | ULTRAFLEX | Boston Scientific Corp | 1996-11-14 | Traditional | PDF ↗ |
| K961507 | WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K961296 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K945494 | WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1995-03-03 | Traditional | PDF ↗ |
| K934116 | WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION | Boston Scientific Scimed, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K891411 | GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT | Cook, Inc. | 1991-12-18 | Traditional | PDF ↗ |
Product code JCT · Class II · General, Plastic Surgery. Data: openFDA.