The following data is part of a premarket notification filed by Alveolus, Inc with the FDA for Aero Tracheobronchial Stent Technology System.
| Device ID | K082284 |
| 510k Number | K082284 |
| Device Name: | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ALVEOLUS, INC 9013 PERIMETER WOODS DR. SUITE A Charlotte, NC 28216 |
| Contact | Tony Alexander |
| Correspondent | Tony Alexander ALVEOLUS, INC 9013 PERIMETER WOODS DR. SUITE A Charlotte, NC 28216 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450030865 | K082284 | 000 |
| 10884450030704 | K082284 | 000 |
| 10884450030711 | K082284 | 000 |
| 10884450030728 | K082284 | 000 |
| 10884450030735 | K082284 | 000 |
| 10884450030742 | K082284 | 000 |
| 10884450030759 | K082284 | 000 |
| 10884450030766 | K082284 | 000 |
| 10884450030773 | K082284 | 000 |
| 10884450030780 | K082284 | 000 |
| 10884450030797 | K082284 | 000 |
| 10884450030803 | K082284 | 000 |
| 10884450030810 | K082284 | 000 |
| 10884450030827 | K082284 | 000 |
| 10884450030834 | K082284 | 000 |
| 10884450030841 | K082284 | 000 |
| 10884450030858 | K082284 | 000 |
| 10884450030698 | K082284 | 000 |