510(k) K152842
- Device
- WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
- Applicant
- BOSTON SCIENTIFIC CORPORATION
- 510(k) number
- K152842
- Product code
- JCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-19
- Date received
- 2015-09-29
- Regulation
- 878.3720
- Classification name
- Prosthesis, Tracheal, Expandable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARAH KUCHARSKI
- Address
- One Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3010173425
- 3009906660
- 3004837686
- 3015309643
- 3010665433
- 3000247987
- 3013337852
- 3006950086
- 3010273872
- 3011175548
- 3009582362
- 3033589330
- 2124215
- 3008146331
- 1123137
- 3005099803
- 3002807314
- 1721676
- 1721504
- 1000121056
- 3011458193
- 1724474
- 3040096051
- 1820334
- 3015225571
- 3013440400
- 3012536737
- 9681260
Source Documents#
Other 510(k) Records For Product Code JCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | 2023-07-14 |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-08 |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | 2021-10-30 |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021-09-01 |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC) | M.I.Tech Co., Ltd. | 2020-12-31 |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | 2018-09-21 |
| K140382 | AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY | Merit Medical Systems, Inc. | 2014-11-25 |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | 2014-10-17 |
| K141584 | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM | Boston Scientific Corporation | 2014-10-16 |
| K121048 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | 2012-08-03 |
| K083625 | AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2009-03-11 |
| K082284 | AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM | Alveolus, Inc. | 2008-11-20 |
| K071604 | ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM | Alveolus, Inc. | 2007-09-19 |
| K062511 | AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX | Alveolus, Inc. | 2007-01-31 |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular, Inc. | 2005-07-07 |
Legacy Summary#
summary
FDA Review#
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