Alveolus, Tb-Sts Tracheobronchial Stent System
FDA 510(k) K033053 · Alveolus, Inc.
510(k) numberK033053
Submission
- Device name
- Alveolus, Tb-Sts Tracheobronchial Stent System
- Applicant
- Alveolus, Inc.
Charlotte, NC, US - Received
- September 29, 2003
- Decision date
- February 25, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCT – Prosthesis, Tracheal, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3720
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code JCT
| 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 |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K083625 | Aero DV Tracheobronchial Stent SystemJCT · Traditional | 03/11/2009SESU |
| K082284 | Aero Tracheobronchial Stent Technology SystemJCT · Traditional | 11/20/2008SESU |
| K080838 | Alveolus Alimaxx-E Esophageal Stent SystemESW · Special | 04/24/2008SE |
| K072720 | Alimaxx-B Uncovered Biliary Stent SystemFGE · Traditional | 04/11/2008SESU |
| K071604 | Alveolus Aero DV Tracheobronchial Stent SystemJCT · Traditional | 09/19/2007SESU |
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XXJCT · Traditional | 01/31/2007SESU |
| K060239 | Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemESW · Traditional | 03/22/2006SE |
| K051621 | Endoventions Alimaxx-E Esophageal Stent SystemESW · Traditional | 07/11/2005SE |
| K033990 | Alveolus Inc. Tb-Sts Tracheobronchial Stent SystemJCT · Special | 05/12/2004SE |
| K032744 | Alveolus Inc., Tb-Sts Tracheobronchial Stent SystemJCT · Traditional | 11/13/2003SE |
Questions and answers
When was Alveolus, Tb-Sts Tracheobronchial Stent System cleared by the FDA?
Alveolus, Tb-Sts Tracheobronchial Stent System (K033053) received a 510(k) decision of Substantially Equivalent on February 25, 2004, 149 days after the submission was received.
What is the product code of K033053?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.