The following data is part of a premarket notification filed by Alveolus, Inc with the FDA for Alveolus Aero Dv Tracheobronchial Stent System.
| Device ID | K071604 |
| 510k Number | K071604 |
| Device Name: | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | ALVEOLUS, INC 9013 PERIMETER WOODS DR. SUITE A Charlotte, NC 28216 |
| Contact | Donald V Canal |
| Correspondent | Donald V Canal 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 | 2007-06-12 |
| Decision Date | 2007-09-19 |