Prosthesis, Tracheal, Expandable
FDA product code JCT · Class II (moderate risk) · 21 CFR 878.3720 · General, Plastic Surgery
45510(k) clearances
0PMA approvals
60recalls
Implantimplanted device
Manufacturers
- Boston Scientific Scimed, Inc. 9
- Alveolus, Inc. 8
- Boston Scientific Corporation 7
- Vascular Architects, Inc. 3
- W. L. Gore & Associates, Inc. 3
- Micro-Tech (Nanjing) Co., Ltd. 3
- Intratherapeutics, Inc. 2
- Bard Peripheral Vascular Inc 2
- Atrium Medical Corporation 2
- Merit Medical Systems, Inc. 2
- Cook, Inc. 1
- Sulzer Intratherapeutics, Inc. 1
- Endochoice, Inc. 1
- M.I.Tech Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230269 | Ultraflex Tracheobronchial Stent SystemJCT · Special | Boston Scientific Corporation | 07/14/2023SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 07/08/2022SE |
| K212403 | Tracheal Stent System (Y-Shaped)JCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 10/30/2021SE |
| K202204 | Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 09/01/2021SE |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC)JCT · Traditional | M.I.Tech Co., Ltd. | 12/31/2020SE |
| K181200 | AEROmini Tracheobronchial Stent SystemJCT · Traditional | Merit Medical Systems, Inc. | 09/21/2018SE |
| K152842 | Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis TracheobronchialJCT · Traditional | Boston Scientific Corporation | 05/19/2016SE |
| K140382 | Aeromini Tracheobronchial Stent TechnologyJCT · Traditional | Merit Medical Systems, Inc. | 11/25/2014SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | Endochoice, Inc. | 10/17/2014SE |
| K141584 | Ultraflex Tracheobronchial Covered Stent SystemJCT · Traditional | Boston Scientific Corporation | 10/16/2014SE |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredJCT · Traditional | Boston Scientific Corp | 08/03/2012SE |
| K083625 | Aero DV Tracheobronchial Stent SystemJCT · Traditional | Alveolus, Inc. | 03/11/2009SESU |
| K082284 | Aero Tracheobronchial Stent Technology SystemJCT · Traditional | Alveolus, Inc. | 11/20/2008SESU |
| K071604 | Alveolus Aero DV Tracheobronchial Stent SystemJCT · Traditional | Alveolus, Inc. | 09/19/2007SESU |
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XXJCT · Traditional | Alveolus, Inc. | 01/31/2007SESU |
| K050832 | Fluency Plus Tracheobronchial Stent GraftJCT · Special | Bard Peripheral Vascular, Inc. | 07/07/2005SE |
| K050814 | Atrium Icast Covered StentJCT · Special | Atrium Medical Corp. | 05/06/2005SE |
| K041269 | Atrium Medical Corporation Icast Covered StentJCT · Traditional | Atrium Medical Corp. | 09/14/2004SE |
| K033990 | Alveolus Inc. Tb-Sts Tracheobronchial Stent SystemJCT · Special | Alveolus, Inc. | 05/12/2004SE |
| K033053 | Alveolus, Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | Alveolus, Inc. | 02/25/2004SE |
| K032744 | Alveolus Inc., Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | Alveolus, Inc. | 11/13/2003SE |
| K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery SystemJCT · Traditional | Vascular Architects, Inc. | 08/01/2003SE |
| K031041 | Fluency Tracheobronchial Stent GraftJCT · Abbreviated | Bard Peripheral Vascular | 06/19/2003SE |
| K030947 | Alveolus Inc., Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | Alveolus, Inc. | 05/15/2003SE |
| K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…JCT · Special | Vascular Architects, Inc. | 03/24/2003SE |
| K024178 | Viatorr EndoprosthesisJCT · Traditional | W. L. Gore & Associates, Inc. | 03/07/2003SE |
| K023811 | Modification to Viabahn EndoprosthesisJCT · Special | W. L. Gore & Associates, Inc. | 12/10/2002SE |
| K021901 | Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special | Boston Scientific Scimed, Inc. | 07/09/2002SE |
| K021563 | Intracoil Self-Expanding Peripheral StentJCT · Special | Sulzer Intratherapeutics, Inc. | 05/31/2002SE |
| K013648 | Viabahn EndoprosthesisJCT · Traditional | W. L. Gore & Associates, Inc. | 01/08/2002SE |
| K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemJCT · Traditional | Vascular Architects, Inc. | 11/15/2001SE |
| K003100 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | Boston Scientific Corp | 12/20/2000SE |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | Boston Scientific Scimed, Inc. | 06/05/2000SE |
| K001257 | Intracoil StentJCT · Special | Intratherapeutics, Inc. | 05/18/2000SE |
| K992510 | Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery SystemJCT · Traditional | Boston Scientific Corp | 11/18/1999SE |
| K990221 | Intracoil Peripheral StentJCT · Traditional | Intratherapeutics, Inc. | 06/02/1999SE |
| K982184 | Wallstent EndoprosthesisJCT · Special | Boston Scientific Scimed, Inc. | 07/21/1998SE |
| K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis…JCT · Traditional | Boston Scientific Scimed, Inc. | 03/13/1998SE |
| K964121 | Wallstent Tracheobronchial EndoprosthesisJCT · Traditional | Boston Scientific Scimed, Inc. | 12/04/1996ST |
| K963241 | UltraflexJCT · Traditional | Boston Scientific Corp | 11/14/1996ST |
| K961507 | Walstent Tracheobronchial EndoprosthesisJCT · Traditional | Boston Scientific Scimed, Inc. | 07/10/1996ST |
| K961296 | Wallstent Tracheobronchial EndoprosthesisJCT · Traditional | Boston Scientific Scimed, Inc. | 07/10/1996ST |
| K945494 | Wallstent(R) Tracheobronchial EndoprosthesisJCT · Traditional | Boston Scientific Scimed, Inc. | 03/03/1995ST |
| K934116 | Wallstent Tracheobronchial Prosthesis ModificationJCT · Traditional | Boston Scientific Scimed, Inc. | 06/02/1994ST |
| K891411 | Gianturco-Wallace Tracheobronchial Z StentJCT · Traditional | Cook, Inc. | 12/18/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1077-2022 Class I | iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405…Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub… | Atrium Medical Corporation | 03/03/2022Open, Classified |
| Z-1076-2022 Class I | Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320…Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub… | Atrium Medical Corporation | 03/03/2022Open, Classified |
| Z-3040-2018 Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-3039-2018 Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-3037-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-3036-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-3035-2018 Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-2761-2017 Class II | Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number…Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA… | Atrium Medical Corporation | 05/25/2017Terminated |
| Z-1567-2016 Class II | Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm…Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm | Boston Scientific Corporation | 03/18/2016Terminated |
| Z-2252-2015 Class II | Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2249-2015 Class II | Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2248-2015 Class II | Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2833-2011 | Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in…Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and… | Boston Scientific Corporation | 05/25/2011Terminated |
| Z-2832-2011 | Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self…Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and… | Boston Scientific Corporation | 05/25/2011Terminated |
| Z-2330-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-2329-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-2328-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-2327-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-2326-2010 | Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-2325-2010 | Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |
| Z-1856-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/60 Catalog Number: M00569930.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1855-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1854-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1853-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1852-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1851-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1850-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1849-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1848-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1847-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1846-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1845-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog Number: M00569500.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1844-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1843-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1842-2010 | Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1841-2010 | Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1840-2010 | Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1839-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1838-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1837-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1836-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1835-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1834-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1833-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1832-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1831-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1830-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1829-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1828-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |
| Z-1827-2010 | Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060.…Suture related device failures during deployment and repositioning of the stent | Boston Scientific Corporation | 05/17/2010Terminated |