NWAClass IIImplant
Prosthesis, Tracheal, Preformed/molded
General, Plastic Surgery · 21 CFR 878.3720
The device is intended to provide support to weakened or constricting airway walls.
MDR events4All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances7All time
Recent MDR events
4 adverse event reports on file
- VISIONAIR 3D STENTApr 8, 2026InjuryVisionair Solutions3010197296-2026-00001
- VISIONAIR 3D STENT (PATIENT-SPECIFIC AIRWAY STENT)Apr 13, 2021InjuryVisionair Solutions3010197296-2021-03291
- VISIONAIR 3D CUSTOM SILICONE AIRWAY Y-STENTMar 31, 2021InjuryVisionair Solutions / New Cos Inc.MW5100477
- BRYAN DUMON SILICONE STENTOct 28, 2019MalfunctionLymol Medical Corporation9244400
Event type breakdown
Injury3
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- VisionAir SolutionsJun 1, 2026
K261541 · VisionAir Enhanced Stock Stent
- Novatech SAOct 29, 2024
K243126 · TRACHEOBRONXANE DUMON®
- New Cos Inc. Dba Visionair SolutionsOct 7, 2022
K213969 · VisionAir Patient-Specific Airway Stent
- New Cos, Inc.Oct 23, 2019
K182743 · Patient-Specific Airway Stent
- Novatech SAAug 21, 1997
K971509 · ENDOXANE
- Bryan Corp.Oct 24, 1989
K894380 · DUMON TRACHEOBRONCHIAL STENT
- Hood LaboratoriesOct 1, 1987
K873742 · HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES