Atrium Medical Corporation Icast Covered Stent
FDA 510(k) K041269 · Atrium Medical Corp.
510(k) numberK041269
Submission
- Device name
- Atrium Medical Corporation Icast Covered Stent
- Applicant
- Atrium Medical Corp.
Hudson, NH, US - Received
- May 12, 2004
- Decision date
- September 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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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| 510(k) | Device | Decision |
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| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | 09/03/2021SE |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicFTL · Traditional | 10/22/2015SE |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugFTL · Traditional | 08/27/2015SE |
| K130142 | Flixene Ifg Vascular GraftDSY · Traditional | 03/15/2013SE |
| K130131 | Edrain Chest Drainage SystemBTA · Traditional | 02/28/2013SE |
| K122138 | Atrium Flixene Ifg Vascular GraftDSY · Special | 08/17/2012SE |
| K121070 | C-Qur RPM MeshFTL · Special | 04/26/2012SE |
| K113112 | Clearway RX NB CatheterDQY · Special | 11/17/2011SE |
| K110110 | Atrium Centrilfx MeshFTL · Special | 02/15/2011SE |
Questions and answers
When was Atrium Medical Corporation Icast Covered Stent cleared by the FDA?
Atrium Medical Corporation Icast Covered Stent (K041269) received a 510(k) decision of Substantially Equivalent on September 14, 2004, 125 days after the submission was received.
What is the product code of K041269?
The FDA product code is JCT – Prosthesis, Tracheal, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3720.