JCT — Prosthesis, Tracheal, Expandable Class II
FDA product code JCT covers "Prosthesis, Tracheal, Expandable", a Class II medical device regulated under 21 CFR 878.3720. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JCT
- Device Class
- Class II
- Regulation Number
- 878.3720
- Submission Type
- Review Panel
- AN
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230269 | boston scientific corporation | Ultraflex Tracheobronchial Stent System | July 14, 2023 |
| K220424 | micro-tech (nanjing) co | Through the Scope Tracheal Stent System | July 8, 2022 |
| K212403 | micro-tech (nanjing) co | Tracheal Stent System (Y-Shaped) | October 30, 2021 |
| K202204 | micro-tech (nanjing) co | Tracheal Stent System | September 1, 2021 |
| K201342 | m.i.tech co | HANAROSTENT Trachea/Bronchium (CCC) | December 31, 2020 |
| K181200 | merit medical systems | AEROmini Tracheobronchial Stent System | September 21, 2018 |
| K152842 | boston scientific corporation | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB | May 19, 2016 |
| K140382 | merit medical systems | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | November 25, 2014 |
| K140472 | endochoice | BONASTENT TRACHEAL / BRONCHIAL | October 17, 2014 |
| K141584 | boston scientific corporation | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | October 16, 2014 |
| K121048 | boston scientific | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | August 3, 2012 |
| K083625 | alveolus | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | March 11, 2009 |
| K082284 | alveolus | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | November 20, 2008 |
| K071604 | alveolus | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | September 19, 2007 |
| K062511 | alveolus | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | January 31, 2007 |
| K050832 | bard peripheral vascular | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | July 7, 2005 |
| K050814 | atrium medical | ATRIUM ICAST COVERED STENT | May 6, 2005 |
| K041269 | atrium medical | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | September 14, 2004 |
| K033990 | alveolus | ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM | May 12, 2004 |
| K033053 | alveolus | ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM | February 25, 2004 |