Ultraflex
FDA 510(k) K963241 · Boston Scientific Corp
510(k) numberK963241
Submission
- Device name
- Ultraflex
- Applicant
- Boston Scientific Corp
Natick,, MA, US - Received
- August 19, 1996
- Decision date
- November 14, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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 |
| K141584 | Ultraflex Tracheobronchial Covered Stent SystemJCT · Traditional | Boston Scientific Corporation | 10/16/2014SE |
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| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
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Questions and answers
When was Ultraflex cleared by the FDA?
Ultraflex (K963241) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 14, 1996, 87 days after the submission was received.
What is the product code of K963241?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.