Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System
FDA 510(k) K012544 · Vascular Architects, Inc.
510(k) numberK012544
Submission
- Device name
- Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System
- Applicant
- Vascular Architects, Inc.
San Jose, CA, US - Received
- August 7, 2001
- Decision date
- November 15, 2001
- 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
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| K212403 | Tracheal Stent System (Y-Shaped)JCT · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 10/30/2021SE |
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| 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 |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K031641 | Vascular Architects Aspire Covered Stent and 718 Delivery SystemJCT · Traditional | 08/01/2003SE |
| K030567 | Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…JCT · Special | 03/24/2003SE |
| K003173 | Aspire Covered Stent and Delivery CatheterESW · Traditional | 03/13/2001SE |
| K003719 | Vascular Architects Periscope DeviceDWX · Traditional | 02/28/2001SE |
Questions and answers
When was Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System cleared by the FDA?
Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System (K012544) received a 510(k) decision of Substantially Equivalent on November 15, 2001, 100 days after the submission was received.
What is the product code of K012544?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.