Product code NWA
- Device name
- Prosthesis, Tracheal, Preformed/Molded
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3720
- Review panel
- AN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended to provide support to weakened or constricting airway walls.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | 2026-06-01 |
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 |
| K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019-10-23 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | 1989-10-24 |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | 1987-10-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860011822677 | VisionAir Enhanced Stock Stent | VisionAir Solutions, LLC | 2026-10-16 |
| 00860011822691 | VisionAir Enhanced Stock Stent | VisionAir Solutions, LLC | 2026-10-16 |
| 00860011822660 | VisionAir Enhanced Stock Stent | VisionAir Solutions, LLC | 2026-10-16 |
| 00860011822653 | VisionAir Enhanced Stock Stent | VisionAir Solutions, LLC | 2026-10-14 |
| 14063108100518 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100501 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100495 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100488 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100464 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100457 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100440 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-20 |
| 14063108100433 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100426 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100358 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100365 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100372 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100389 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100396 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100402 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 14063108100419 | TRACHEOBRONXANE™ DUMON® | NOVATECH | 2024-11-19 |
| 10197106720929 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-11-15 |
| 10197106748596 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-09-11 |
| 10197106701485 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-08-21 |
| 10197106693247 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-23 |
| 00860011822608 | VisionAir 3D Stent | VisionAir Solutions, LLC | 2024-05-01 |
| 10197106477182 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-11-27 |
| 10197106437001 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-10-02 |
| 10197106256770 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-05-02 |
| 10197106139233 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-02-16 |
| 10195594321116 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-01 |