The following data is part of a premarket notification filed by Alveolus, Inc with the FDA for Aero Dv Tracheobronchial Stent System.
| Device ID | K083625 |
| 510k Number | K083625 |
| Device Name: | AERO DV TRACHEOBRONCHIAL STENT 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 | 2008-12-08 |
| Decision Date | 2009-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450031015 | K083625 | 000 |
| 10884450030889 | K083625 | 000 |
| 10884450030896 | K083625 | 000 |
| 10884450030902 | K083625 | 000 |
| 10884450030919 | K083625 | 000 |
| 10884450030926 | K083625 | 000 |
| 10884450030933 | K083625 | 000 |
| 10884450030940 | K083625 | 000 |
| 10884450030957 | K083625 | 000 |
| 10884450030964 | K083625 | 000 |
| 10884450030971 | K083625 | 000 |
| 10884450030988 | K083625 | 000 |
| 10884450030995 | K083625 | 000 |
| 10884450031008 | K083625 | 000 |
| 10884450030872 | K083625 | 000 |