K181200 is an FDA 510(k) clearance for the AEROmini Tracheobronchial Stent System. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 21, 2018, 137 days after receiving the submission on May 7, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K181200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2018 |
| Decision Date | September 21, 2018 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |