Tracheal Stent System (Y-Shaped)
The Y-shaped Tracheal Stent System supports a narrowed tracheobronchial airway with a single implant that follows the main airway and its two branches. A flexible delivery system carries…
The Y-shaped Tracheal Stent System supports a narrowed tracheobronchial airway with a single implant that follows the main airway and its two branches. A flexible delivery system carries the self-expanding stent in a constrained state before release.
The stent is woven from Nitinol wire and partially covered with silicone to restrict tumor growth through the mesh. The Y geometry joins one main section and two branch sections around the airway bifurcation.
Listed Item
Y-Shaped, main body14×30, one branch10×25, the other branch10×15, Partially Covered, Delivery System 6*650
Positioning Features
Radiopaque markers aid fluoroscopic visibility, and retrieval loops allow repositioning during initial placement. The delivery sheath constrains the implant until deployment; the stent then supplies the airway support. The system is supplied sterile for single use.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K212403 |
| Record published | 2023-02-03 |
| Record revised | 2026-01-19 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Stent diameter 14 to 22 mm; stent length 30 to 60 mm; shaft length 30 to 50 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NST02-962-18.040-240 | Stent Diameter 18 mm | In distribution |
| NST02-962-18.060-235 | Stent Diameter 18 mm | In distribution |
| NST02-962-20.060-106 | Stent Diameter 20 mm | In distribution |
| NST02-962-18.040-235 | Stent Diameter 18 mm | In distribution |
| NST02-962-14.030-100 | Stent Diameter 14 mm | In distribution |
| NST02-962-16.040-78 | Stent Diameter 16 mm | In distribution |
| NST02-962-18.060-240 | Stent Diameter 18 mm | In distribution |
| NST02-962-20.050-106 | Stent Diameter 20 mm | In distribution |
| NST02-962-18.040-234 | Stent Diameter 18 mm | In distribution |
| NST02-962-20.060-111 | Stent Diameter 20 mm | In distribution |
| NST02-964-14.030-98 | Stent Diameter 14 mm | In distribution |
| NST02-962-22.060-111 | Stent Diameter 22 mm | In distribution |
| NST02-962-20.050-111 | Stent Diameter 20 mm | In distribution |
| NST02-962-20.060-110 | Stent Diameter 20 mm | In distribution |
| NST02-962-18.060-239 | Stent Diameter 18 mm | In distribution |
| NST02-962-20.050-105 | Stent Diameter 20 mm | In distribution |
| NST02-964-14.030-100 | Stent Diameter 14 mm | In distribution |
| NST02-962-16.040-77 | Stent Diameter 16 mm | In distribution |
| NST02-962-14.030-97 | Stent Diameter 14 mm | In distribution |
| NST02-962-18.060-234 | Stent Diameter 18 mm | In distribution |
| NST02-962-14.030-99 | Stent Diameter 14 mm | In distribution |
| NST02-962-14.030-98 | Stent Diameter 14 mm | In distribution |
| NST02-962-20.060-105 | Stent Diameter 20 mm | In distribution |
| NST02-962-20.050-110 | Stent Diameter 20 mm | In distribution |
| NST02-964-14.030-99 | Stent Diameter 14 mm | In distribution |
| NST02-964-14.030-97 | Shaft Length 30 mm | In distribution |
| NST02-962-18.040-239 | Stent Diameter 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanarostent® Trachea/Bronchium(CCC) | M.I.Tech Co Ltd | 84 |
| Bonastent® Tracheal/Bronchial | Sewoon Medical Co., Ltd. | 83 |
| Aero® | Merit Medical Systems, Inc. | 37 |
| Ultraflex™ Tracheobronchial | Boston Scientific Corporation | 36 |
| iCAST | Atrium Medical Corporation | 34 |
| Wallstent™ RP Endoprosthesis | Boston Scientific Corporation | 32 |
| Aero DV® | Merit Medical Systems, Inc. | 27 |
| Wallgraft® | Boston Scientific Corporation | 25 |
| AEROmini® | Merit Medical Systems, Inc. | 25 |
| Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 17 |
| Wallstent® Endoprosthesis | Boston Scientific Corporation | 16 |
| Gianturco-Rosch Cook-Z | Cook Incorporated | 5 |
Showing 12 of 14. All products under Prosthesis, Tracheal, Expandable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220424 | 2022-07-08 |
| K212403 | 2021-10-30 |
| K202204 | 2021-09-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.