The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Aeromini Tracheobronchial Stent System.
| Device ID | K181200 |
| 510k Number | K181200 |
| Device Name: | AEROmini Tracheobronchial Stent System |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450307950 | K181200 | 000 |
| 10884450307936 | K181200 | 000 |
| 10884450307929 | K181200 | 000 |
| 10884450307912 | K181200 | 000 |
| 10884450307875 | K181200 | 000 |