Home › Device types › JCT
Prosthesis, Tracheal, Expandable
FDA product code JCT · Class 2 · General, Plastic Surgery
452
Registered devices
3,007
Adverse events
61
Recalls
45
510(k) clearances
Devices with this code
iCAST — Atrium Medical CorporationHANAROSTENT® Trachea/Bronchium(CCC) — M.I.Tech Co., Ltd.AERO DV® — Merit Medical Systems, Inc.iCAST — Atrium Medical CorporationWALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONHANAROSTENT® Trachea/Bronchium(CCC) — M.I.Tech Co., Ltd.WALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONAERO DV® — Merit Medical Systems, Inc.AEROmini® — Merit Medical Systems, Inc.Tracheal Stent system (Y-shaped) — Micro-Tech (Nanjing) Co., Ltd.iCAST — Atrium Medical CorporationiCAST — Atrium Medical CorporationThrough the Scope Tracheal Stent System — Micro-Tech (Nanjing) Co., Ltd.WALLGRAFT® — BOSTON SCIENTIFIC CORPORATIONAERO® — Merit Medical Systems, Inc.iCAST — Atrium Medical CorporationBONASTENT® Tracheal/Bronchial — Sewoon Medical Co., Ltd.BONASTENT® Tracheal/Bronchial — Sewoon Medical Co., Ltd.WALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONAERO® — Merit Medical Systems, Inc.HANAROSTENT® Trachea/Bronchium(CCC) — M.I.Tech Co., Ltd.WALLSTENT™ RP Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONHANAROSTENT® Trachea/Bronchium(CCC) — M.I.Tech Co., Ltd.HANAROSTENT® Trachea/Bronchium(CCC) — M.I.Tech Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-03 | Atrium Medical Corporation | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system w |
| 2022-03-03 | Atrium Medical Corporation | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system w |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2017-05-25 | Atrium Medical Corporation | Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (cathe |
| 2016-03-18 | Boston Scientific Corporation | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that |
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