AEROmini Tracheobronchial Stent System
FDA 510(k) K181200 · Merit Medical Systems, Inc.
510(k) numberK181200
Submission
- Device name
- AEROmini Tracheobronchial Stent System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- May 7, 2018
- Decision date
- September 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCT – Prosthesis, Tracheal, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3720
- Specialty
- General, Plastic Surgery
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code JCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230269 | Ultraflex Tracheobronchial Stent SystemJCT · Special | Boston Scientific Corporation | 07/14/2023SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 07/08/2022SE |
| K212403 | Tracheal Stent System (Y-Shaped)JCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 10/30/2021SE |
| K202204 | Tracheal Stent SystemJCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 09/01/2021SE |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC)JCT · Traditional | M.I.Tech Co., Ltd. | 12/31/2020SE |
| K152842 | Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis TracheobronchialJCT · Traditional | Boston Scientific Corporation | 05/19/2016SE |
| K140382 | Aeromini Tracheobronchial Stent TechnologyJCT · Traditional | Merit Medical Systems, Inc. | 11/25/2014SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | Endochoice, Inc. | 10/17/2014SE |
| K141584 | Ultraflex Tracheobronchial Covered Stent SystemJCT · Traditional | Boston Scientific Corporation | 10/16/2014SE |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredJCT · Traditional | Boston Scientific Corp | 08/03/2012SE |
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| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
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Questions and answers
When was AEROmini Tracheobronchial Stent System cleared by the FDA?
AEROmini Tracheobronchial Stent System (K181200) received a 510(k) decision of Substantially Equivalent on September 21, 2018, 137 days after the submission was received.
What is the product code of K181200?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.