The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Aeromini Tracheobronchial Stent Technology.
| Device ID | K140382 |
| 510k Number | K140382 |
| Device Name: | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dan Lindsay |
| Correspondent | Dan Lindsay MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. 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 | 2014-02-14 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450362768 | K140382 | 000 |
| 10884450230999 | K140382 | 000 |
| 10884450230982 | K140382 | 000 |
| 10884450230968 | K140382 | 000 |
| 10884450229917 | K140382 | 000 |
| 10884450229856 | K140382 | 000 |
| 10884450229849 | K140382 | 000 |
| 10884450229832 | K140382 | 000 |
| 10884450229825 | K140382 | 000 |