Ultraflex Tracheobronchial Covered Stent System
FDA 510(k) K141584 · Boston Scientific Corporation
510(k) numberK141584
Submission
- Device name
- Ultraflex Tracheobronchial Covered Stent System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- June 13, 2014
- Decision date
- October 16, 2014
- 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 |
| K181200 | AEROmini Tracheobronchial Stent SystemJCT · Traditional | Merit Medical Systems, Inc. | 09/21/2018SE |
| 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 |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredJCT · Traditional | Boston Scientific Corp | 08/03/2012SE |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Ultraflex Tracheobronchial Covered Stent System cleared by the FDA?
Ultraflex Tracheobronchial Covered Stent System (K141584) received a 510(k) decision of Substantially Equivalent on October 16, 2014, 125 days after the submission was received.
What is the product code of K141584?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.