Through the Scope Tracheal Stent System
The Through the Scope Tracheal Stent System delivers a self-expanding airway stent through an endoscope working channel. The stent is a woven Nitinol mesh fully covered by a silicone…
The Through the Scope Tracheal Stent System delivers a self-expanding airway stent through an endoscope working channel. The stent is a woven Nitinol mesh fully covered by a silicone membrane with a Parylene N surface layer.
The preloaded delivery system constrains the stent inside an outer sheath. Retracting the sheath releases the stent under direct endoscopic visualization, with the handle controlling deployment.
Listed Item
Double spherical 10×30 mm, Covered ,2.7*1200
Delivery and Retrieval Features
Two coaxial sheaths and an inner core support delivery, with locks that prevent premature exposure. Retrieval loops at both stent ends assist adjustment or removal during placement. The system is supplied sterile for single use and is designed for an endoscope channel of at least 2.8 mm.
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) | K220424 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-08 (version 4) |
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 10 to 18 mm; stent length 20 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NST12-334-10.030 | Stent Diameter 10 mm | In distribution |
| NST12-334-16.060 | Stent Diameter 16 mm | In distribution |
| NST12-334-14.030 | Stent Diameter 14 mm | In distribution |
| NST12-334-12.030 | Stent Diameter 12 mm | In distribution |
| NST12-334-12.020 | Stent Diameter 12 mm | In distribution |
| NST12-334-10.040 | Stent Diameter 10 mm | In distribution |
| NST12-334-16.050 | Stent Diameter 16 mm | In distribution |
| NST12-334-18.080 | Stent Diameter 18 mm | In distribution |
| NST12-334-18.040 | Stent Diameter 18 mm | In distribution |
| NST12-334-16.080 | Stent Diameter 16 mm | In distribution |
| NST12-334-14.020 | Stent Diameter 14 mm | In distribution |
| NST12-334-10.020 | Stent Diameter 10 mm | In distribution |
| NST12-334-16.040 | Stent Diameter 16 mm | In distribution |
| NST12-334-18.060 | Stent Diameter 18 mm | In distribution |
| NST12-334-18.050 | Stent Diameter 18 mm | In distribution |
| NST12-334-14.040 | Stent Diameter 14 mm | In distribution |
| NST12-334-12.040 | Stent Diameter 12 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 |
| Tracheal Stent system (Y-shaped) | Micro-Tech (Nanjing) Co., Ltd. | 27 |
| Aero DV® | Merit Medical Systems, Inc. | 27 |
| Wallgraft® | Boston Scientific Corporation | 25 |
| AEROmini® | Merit Medical Systems, Inc. | 25 |
| 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.