Hanarostent® Trachea/Bronchium(CCC)
Hanarostent Trachea/Bronchium CCC is a self-expanding airway stent for narrowing caused by malignant tumors. A nitinol wire frame exerts outward support within the tracheal or bronchial…
Hanarostent Trachea/Bronchium CCC is a self-expanding airway stent for narrowing caused by malignant tumors. A nitinol wire frame exerts outward support within the tracheal or bronchial lumen.
A silicone membrane fully covers the metal frame, and a repositioning lasso is attached at one end. The stent is supplied constrained within a polymer delivery system.
Listed Item
Full Covered metallic tracheal stent
Deployment
The delivery system advances to the target over a 0.035-inch guidewire. Withdrawing its outer sheath releases the stent, which expands against the airway wall. Radiopaque markers support positioning under fluoroscopy. The delivery system is removed after deployment; the stent and delivery assembly are supplied sterile for single use.
1manufacturer
84catalogue numbers in this listing
1510(k) clearance
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 | M.I.Tech Co Ltd, South Korea |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K201342 |
| Record published | 2021-04-30 |
| Record revised | 2026-01-02 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 35 °C |
| Sizes | Stent diameter 10 to 20 mm; stent length 20 to 80 mm; shaft length 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCS-14-030-090 | Stent Diameter 14 mm | In distribution |
| TCS-14-040-090 | Stent Diameter 14 mm | In distribution |
| TCS-20-080-090 | Stent Diameter 20 mm | In distribution |
| TCS-18-020-050 | Stent Diameter 18 mm | In distribution |
| TCS-20-050-050 | Stent Diameter 20 mm | In distribution |
| TCS-12-030-050 | Stent Diameter 12 mm | In distribution |
| TCS-16-050-050 | Stent Diameter 16 mm | In distribution |
| TCS-10-020-090 | Stent Diameter 10 mm | In distribution |
| TCS-20-020-090 | Stent Diameter 20 mm | In distribution |
| TCS-12-020-090 | Stent Diameter 12 mm | In distribution |
| TCS-12-070-090 | Stent Diameter 12 mm | In distribution |
| TCS-20-040-050 | Stent Diameter 20 mm | In distribution |
| TCS-20-070-090 | Stent Diameter 20 mm | In distribution |
| TCS-14-060-050 | Stent Diameter 14 mm | In distribution |
| TCS-18-040-050 | Stent Diameter 18 mm | In distribution |
| TCS-18-050-090 | Stent Diameter 18 mm | In distribution |
| TCS-10-080-050 | Stent Diameter 10 mm | In distribution |
| TCS-18-040-090 | Stent Diameter 18 mm | In distribution |
| TCS-20-030-050 | Stent Diameter 20 mm | In distribution |
| TCS-10-060-090 | Stent Diameter 10 mm | In distribution |
| TCS-20-060-090 | Stent Diameter 20 mm | In distribution |
| TCS-14-050-050 | Stent Diameter 14 mm | In distribution |
| TCS-12-080-090 | Stent Diameter 12 mm | In distribution |
| TCS-16-030-050 | Stent Diameter 16 mm | In distribution |
| TCS-20-070-050 | Stent Diameter 20 mm | In distribution |
| TCS-18-060-090 | Stent Diameter 18 mm | In distribution |
| TCS-16-060-050 | Stent Diameter 16 mm | In distribution |
| TCS-16-040-050 | Stent Diameter 16 mm | In distribution |
| TCS-10-050-090 | Stent Diameter 10 mm | In distribution |
| TCS-10-040-090 | Stent Diameter 10 mm | In distribution |
| TCS-20-060-050 | Stent Diameter 20 mm | In distribution |
| TCS-18-060-050 | Stent Diameter 18 mm | In distribution |
| TCS-18-030-050 | Stent Diameter 18 mm | In distribution |
| TCS-18-080-090 | Stent Diameter 18 mm | In distribution |
| TCS-16-070-050 | Stent Diameter 16 mm | In distribution |
| TCS-14-070-090 | Stent Diameter 14 mm | In distribution |
| TCS-14-030-050 | Stent Diameter 14 mm | In distribution |
| TCS-14-020-050 | Stent Diameter 14 mm | In distribution |
| TCS-20-050-090 | Stent Diameter 20 mm | In distribution |
| TCS-14-070-050 | Stent Diameter 14 mm | In distribution |
| TCS-14-080-050 | Stent Diameter 14 mm | In distribution |
| TCS-12-030-090 | Stent Diameter 12 mm | In distribution |
| TCS-16-080-050 | Stent Diameter 16 mm | In distribution |
| TCS-10-020-050 | Stent Diameter 10 mm | In distribution |
| TCS-20-030-090 | Stent Diameter 20 mm | In distribution |
| TCS-18-050-050 | Stent Diameter 18 mm | In distribution |
| TCS-14-040-050 | Stent Diameter 14 mm | In distribution |
| TCS-12-080-050 | Stent Diameter 12 mm | In distribution |
| TCS-10-080-090 | Stent Diameter 10 mm | In distribution |
| TCS-12-040-090 | Stent Diameter 12 mm | In distribution |
| TCS-18-070-050 | Stent Diameter 18 mm | In distribution |
| TCS-12-050-050 | Stent Diameter 12 mm | In distribution |
| TCS-16-040-090 | Stent Diameter 16 mm | In distribution |
| TCS-12-040-050 | Stent Diameter 12 mm | In distribution |
| TCS-10-030-090 | Stent Diameter 10 mm | In distribution |
| TCS-18-030-090 | Stent Diameter 18 mm | In distribution |
| TCS-18-070-090 | Stent Diameter 18 mm | In distribution |
| TCS-20-080-050 | Stent Diameter 20 mm | In distribution |
| TCS-10-060-050 | Stent Diameter 10 mm | In distribution |
| TCS-14-080-090 | Stent Diameter 14 mm | In distribution |
| TCS-18-080-050 | Stent Diameter 18 mm | In distribution |
| TCS-10-070-090 | Stent Diameter 10 mm | In distribution |
| TCS-12-050-090 | Stent Diameter 12 mm | In distribution |
| TCS-16-080-090 | Stent Diameter 16 mm | In distribution |
| TCS-16-050-090 | Stent Diameter 16 mm | In distribution |
| TCS-16-060-090 | Stent Diameter 16 mm | In distribution |
| TCS-14-060-090 | Stent Diameter 14 mm | In distribution |
| TCS-14-050-090 | Stent Diameter 14 mm | In distribution |
| TCS-10-040-050 | Stent Diameter 10 mm | In distribution |
| TCS-20-020-050 | Stent Diameter 20 mm | In distribution |
| TCS-16-020-090 | Stent Diameter 16 mm | In distribution |
| TCS-10-050-050 | Stent Diameter 10 mm | In distribution |
| TCS-10-030-050 | Stent Diameter 10 mm | In distribution |
| TCS-12-060-090 | Stent Diameter 12 mm | In distribution |
| TCS-18-020-090 | Stent Diameter 18 mm | In distribution |
| TCS-12-060-050 | Stent Diameter 12 mm | In distribution |
| TCS-12-020-050 | Stent Diameter 12 mm | In distribution |
| TCS-14-020-090 | Stent Diameter 14 mm | In distribution |
| TCS-16-070-090 | Stent Diameter 16 mm | In distribution |
| TCS-20-040-090 | Stent Diameter 20 mm | In distribution |
| TCS-16-020-050 | Stent Diameter 16 mm | In distribution |
| TCS-12-070-050 | Stent Diameter 12 mm | In distribution |
| TCS-16-030-090 | Stent Diameter 16 mm | In distribution |
| TCS-10-070-050 | Stent Diameter 10 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K201342 | 2020-12-31 |
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.